Unitron Industries, Inc.
Mchenry, IL, US
Unitron Industries, Inc. appears in FDA device records in Mchenry, IL. FDA records list 69 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 69
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 69FDA records hold 69 510(k) clearances for Unitron Industries, Inc. between 1976 and 1997. The busiest year on record is 1995, with 8. The most recent is 1997, with 5.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1978 | 4 |
| 1979 | 2 |
| 1980 | 2 |
| 1981 | 4 |
| 1982 | 7 |
| 1983 | 4 |
| 1984 | 1 |
| 1985 | 6 |
| 1986 | 2 |
| 1987 | 1 |
| 1988 | 2 |
| 1989 | 1 |
| 1990 | 2 |
| 1991 | 3 |
| 1993 | 3 |
| 1994 | 3 |
| 1995 | 8 |
| 1996 | 8 |
| 1997 | 5 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K974340 | UNITRON MODEL SOUND F/XP PROGRAMMABLE MINI BTE | ESD | Substantially Equivalent | |
| K974339 | UNITRON MODEL SOUND F/XD PROGRAMMABLE | ESD | Substantially Equivalent | |
| K974338 | UNITRON MODEL F/X PROGRAMMABLE (MINI BTE) | ESD | Substantially Equivalent | |
| K970692 | UNITRON MODEL SOUND F/X CIC | ESD | Substantially Equivalent | |
| K970519 | UNITRON MODEL SOUND F/X PROGRAMMABLE ITE (SF/X PROGRAMMABLE) | ESD | Substantially Equivalent | |
| K964511 | UNITRON MODEL SOUND F/XD +4 (SOUND F/XD +4) | ESD | Substantially Equivalent | |
| K964510 | UNITRON MODEL ICON AOHPD +4 (ICON AOHPD +4) | ESD | Substantially Equivalent | |
| K964508 | UNITRON MODEL ICON AOHP +4 (ICON AOHP +4) | ESD | Substantially Equivalent | |
| K964504 | UNITRON MODEL ICON AOHPL +4 | ESD | Substantially Equivalent | |
| K964503 | UNITRON MODEL SOUND F/X +4 | ESD | Substantially Equivalent | |
| K964502 | UNITRON MODEL SOUND F/XP +4 | ESD | Substantially Equivalent | |
| K963122 | UNITRON MODEL ICON KR | ESD | Substantially Equivalent | |
| K960155 | UNITRON MODEL SOUND F/XP | ESD | Substantially Equivalent | |
| K954516 | UNITRON MODEL SOUND F/X II | ESD | Substantially Equivalent | |
| K953932 | UNITRON MODEL SOUND F/XD | ESD | Substantially Equivalent | |
| K953727 | UNITRON MODEL IKON AOHPD | ESD | Substantially Equivalent | |
| K954430 | UNITRON MODEL SOUND F/X | ESD | Substantially Equivalent | |
| K953646 | UNITRON MODEL IKON AOHPL | ESD | Substantially Equivalent | |
| K950759 | UNITRON MODEL ESTEEM | ESD | Substantially Equivalent | |
| K946323 | UNITRON MODEL VISTA 1000 SIGMA, AIR CONDUCTION HEARING AID | ESD | Substantially Equivalent | |
| K946264 | UNITRON MODEL SOUNG F/S | ESD | Substantially Equivalent | |
| K944520 | AIR CONDUCTION HEARING AID | ESD | Substantially Equivalent | |
| K935867 | AIR CONDUCTION HEARING AID, UNITRON IKON K & KD | ESD | Substantially Equivalent | |
| K936106 | AIR CONDUCTION HEARING AID: IKON PP | ESD | Substantially Equivalent | |
| K934565 | UNITRON MODEL IKON AGCO/ AOD | ESD | Substantially Equivalent | |
| K934586 | PROGRAMMABLE AIR CONDUCTION BEHIND THE EAR HEARING AID | ESD | Substantially Equivalent | |
| K925600 | VISTA 4000 SIGMA | ESD | Substantially Equivalent | |
| K914689 | HEARING AID, UNITRON MODEL VISTA 4000 | ESD | Substantially Equivalent | |
| K914688 | HEARING AID, UNITRON MODEL VISTA 3000 | ESD | Substantially Equivalent | |
| K912870 | HEARING AID, UNITRON MODEL UIK | ESD | Substantially Equivalent | |
| K904576 | HEARING AID, UNITRON MODEL UM60-UH | ESD | Substantially Equivalent | |
| K901569 | BTE HEARING AID, UNITRON MODELS US80PP AND US80PPL | ESD | Substantially Equivalent | |
| K884288 | HEARING AID, UNITRON BTE MODEL UM60-AGC0 | ESD | Substantially Equivalent | |
| K883513 | HEARING AID, UNITRON MODEL VISTA 1000 | ESD | Substantially Equivalent | |
| K882375 | HEARING AID, UNITRON MODEL UI5 | ESD | Substantially Equivalent | |
| K870503 | HEARING AID, UNITRON MODEL UM60 | ESD | Substantially Equivalent | |
| K863225 | UNITRON MODEL UL21 HEARING AID | ESD | Substantially Equivalent | |
| K862760 | HEARING AID, UNITRON MODEL UF11 | ESD | Substantially Equivalent | |
| K853781 | UNITRON MODEL UM60-PP | ESD | Substantially Equivalent | |
| K853780 | UNITRON MODEL UM60-D | ESD | Substantially Equivalent | |
| K852690 | HEARING AID, UNITRON MODEL UM60-H | ESD | Substantially Equivalent | |
| K850914 | HEARING AID, UNITRON MODEL UC | ESD | Substantially Equivalent | |
| K843246 | HEARING AID, UNITRON UE12-PPL | ESD | Substantially Equivalent | |
| K843245 | HEARING AID, UNITRON UE12-PP | ESD | Substantially Equivalent | |
| K840842 | HEARING AID UNITRON UE8 | ESD | Substantially Equivalent | |
| K833615 | HEARING AID UNITRON UI3 | ESD | Substantially Equivalent | |
| K833614 | HEARING AID, UNITRON UT1 | ESD | Substantially Equivalent | |
| K831883 | HEARING AID UNITRON #UE8-D | ESD | Substantially Equivalent | |
| K830402 | HEARING AID, #UE7-D | ESD | Substantially Equivalent | |
| K823669 | HEARING AID UNITRON #UE4-H | ESD | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain