Rastronics USA, Inc.
Mountainside, NJ, US
Rastronics USA, Inc. appears in FDA device records in Mountainside, NJ. FDA records list 5 510(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
- 5
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 5 510(k) clearances for Rastronics USA, Inc. between 1985 and 1990. The busiest year on record is 1990, with 3. The most recent is 1990, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 1 |
| 1989 | 1 |
| 1990 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K902244 | RASTRONICS CCI 8 | ETW | Substantially Equivalent | |
| K902252 | RASTRONICS CCI 10/3 HEARING AID ANALYSIS | ETW | Substantially Equivalent | |
| K902287 | RASTRONICS PORTAREM 20 | EJT | Substantially Equivalent | |
| K890864 | HANDTYMP SCREENER MODEL 2000 + 2002 REMOTE TRANS. | ETY | Substantially Equivalent | |
| K853320 | FREQUENCY RESPONSE ANALYZER COMPUTER SYS CCI-10 | ETW | 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