Edentec Corp.
Eden Prairie, MN, US
Edentec Corp. appears in FDA device records in Eden Prairie, MN. FDA records list 18 510(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
- 18
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 18 510(k) clearances for Edentec Corp. between 1985 and 1996. The busiest year on record is 1989, with 5. The most recent is 1996, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 1 |
| 1987 | 2 |
| 1988 | 2 |
| 1989 | 5 |
| 1990 | 1 |
| 1991 | 3 |
| 1992 | 1 |
| 1993 | 1 |
| 1995 | 1 |
| 1996 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K953363 | OXIFLOW DIGITAL RECORDER | BZQ | Substantially Equivalent - Subject to Tracking Reg. | |
| K953540 | EEE | BYD | Substantially Equivalent | |
| K921819 | EDENTEC MODEL 3710 I DIGITAL PRINTER | BZQ | Substantially Equivalent | |
| K913749 | EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170 | BZQ | Substantially Equivalent | |
| K910871 | EDENTEC DIGITAL CHARTER MODEL 3710 | DSF | Substantially Equivalent | |
| K910870 | EDENTEC MODEL 3711 DIGITAL RECORDER | DRT | Substantially Equivalent | |
| K905575 | MODIFIED MODELS 2000W AND 2000W OPTION H APNEA MON | BZQ | Substantially Equivalent | |
| K901060 | EDENTEC MODEL 2000W SYSTEM 700 MONITOR | DQA | Substantially Equivalent | |
| K893561 | EDENTRACE 670 SYSTEM MULTICHANNEL RECORDER W/OXIM. | DSF | Substantially Equivalent | |
| K892227 | EDENTEC MODEL 2001 MODULAR MEMORY UNIT (MMU) | DSH | Substantially Equivalent | |
| K891540 | EDENTEC MODEL 2860 PRESSURE METER | BYE | Substantially Equivalent | |
| K884614 | EDENTEC MODEL 2000W OPTION S CARDIO-RESP. PROCESS. | DQA | Substantially Equivalent | |
| K884388 | EDENTEC MODEL 4700 SCANNER | DSF | Substantially Equivalent | |
| K883315 | EDENTRACE MULTI-CHARTER MODEL 3700 | DSF | Substantially Equivalent | |
| K881820 | EDENTEC MODEL 2800/2801 OXIMETER/PULSE OXIMETER | DQA | Substantially Equivalent | |
| K873081 | EDENTEC MULTI-CHANNEL RECORDER | DQA | Substantially Equivalent | |
| K871302 | MODEL 2000W OPTION H CONFIGURATION | BZQ | Substantially Equivalent | |
| K844327 | EDENTEC MODEL 2000W APNEA MONITOR | BZQ | 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