COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E
FDA 510(k) clearance K023354 · decided 2003-09-05
Clearance details
- K-number
- K023354
- Device name
- COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E
- Applicant
- Siemens Elema AB
- Decision
- Substantially Equivalent
- Date received
- 2002-10-07
- Decision date
- 2003-09-05
- Days to decision
- 333 days
- Clearance type
- Traditional
- Product code
- BTI
- Device class
- 2
- Regulation number
- 868.6250
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Danvers, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Compressor Mini To provide a supply of dry, filtered compressed air for a medical respirat recall (Z-0848-2014) | Maquet Cardiovascular Us Sales, Llc | 2014-01-28 |