Drager, Inc.
Pittsburgh, PA, US
Drager, Inc. appears in FDA device records in Pittsburgh, PA. FDA records list 20 510(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
- 20
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 20 510(k) clearances for Drager, Inc. between 1991 and 1999. The busiest year on record is 1995, with 4. The most recent is 1999, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1991 | 1 |
| 1994 | 2 |
| 1995 | 4 |
| 1996 | 4 |
| 1997 | 3 |
| 1998 | 4 |
| 1999 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K992608 | ATC OPTION FOR EVITA 2 DURA AND EVITA 4 | CBK | Substantially Equivalent | |
| K984577 | DRAGER OXYLOG 2000 | CBK | Substantially Equivalent | |
| K983219 | NEOFLOW OPTION MODEL NUMBERS 8413563, 8411900 | CBK | Substantially Equivalent | |
| K982789 | MEDICAL AIR COMPRESSOR, MODEL # 8413419 | BTI | Substantially Equivalent | |
| K980642 | EVITA 4 (8411900) | CBK | Substantially Equivalent | |
| K974176 | BABYLOG 8000 PLUS | CBK | Substantially Equivalent | |
| K971198 | BABYTHERM 8004 BABYTHERM 8010 | FMT | Substantially Equivalent | |
| K970165 | EVITA 2 DURA | CBK | Substantially Equivalent - Subject to Tracking Reg. | |
| K954204 | DRAGER INCUBATOR 8000 IC | FMZ | Substantially Equivalent | |
| K961687 | EVITA 4 | CBK | Substantially Equivalent - Subject to Tracking Reg. | |
| K950853 | OPTIONAL DISPLAY AND SOFTWARE FOR DRAGER VENTILATORS | CBK | Substantially Equivalent - Subject to Tracking Reg. | |
| K953238 | DRAGER MICRO VENT | CBK | Substantially Equivalent - Subject to Tracking Reg. | |
| K953489 | DRAGER INFANT RADIANT WARMERN RH600 | FMT | Substantially Equivalent | |
| K954611 | DRAGER PT4000 PHOTOTHERAPY SYSTEM | LBI | Substantially Equivalent | |
| K943531 | OXYLOG 2000 | CBK | Substantially Equivalent - Subject to Tracking Reg. | |
| K945467 | BABYTHERM 8000 WB | ILO | Substantially Equivalent | |
| K951126 | DRAGER MEDICAL AIR COMPRESSOR | BTL | Substantially Equivalent | |
| K926292 | BABYLOG 8000 INFANT VENTILATOR | CBK | Substantially Equivalent | |
| K924930 | EVITA | CBK | Substantially Equivalent | |
| K903089 | BABYLOG 8000 INFANT VENTILATOR | CBK | 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