Draeger Medical AG & Co. KG
Telford, PA, US
Draeger Medical AG & Co. KG appears in FDA device records in Telford, PA. FDA records list 10 510(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
- 10
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 10 510(k) clearances for Draeger Medical AG & Co. KG between 2008 and 2010. The busiest year on record is 2008, with 6. The most recent is 2010, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 6 |
| 2009 | 1 |
| 2010 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K102618 | VENTSTAR HEATED, INFINITY ID BREATHING CIRCUIT HEATED | BTT | Substantially Equivalent | |
| K092029 | VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310 | BYE | Substantially Equivalent | |
| K100941 | INFINITY MCABLE - MAINSTREAM CO2 | CCK | Substantially Equivalent | |
| K092999 | NBP CUFF | DXQ | Substantially Equivalent | |
| K083050 | EVITE XL | CBK | Substantially Equivalent | |
| K081447 | FOURTH GAS MODULE WITH CO2 FOR PRIMUS US APOLLO | BSZ | Substantially Equivalent | |
| K081743 | CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKS | CBK | Substantially Equivalent | |
| K072884 | FABIUS MRI | BSZ | Substantially Equivalent | |
| K072885 | CARINA SYSTEM, MODEL 8419350; CARINA BASIC DEVICE, MODEL 5704110 | CBK | Substantially Equivalent | |
| K072002 | FILTER CARESTAR 30; FILTER SAFESTAR 55; FILTER/HME TWINSTAR 55 | CAH | 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