PRIMUS US
FDA 510(k) clearance K042607 · decided 2004-11-26
Clearance details
- K-number
- K042607
- Device name
- PRIMUS US
- Applicant
- Draeger Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-09-24
- Decision date
- 2004-11-26
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- BSZ
- Device class
- 2
- Regulation number
- 868.5160
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Telford, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Stabilet Infant Warming System, model numbers 200, 300, 1250, 1500, 200/3000, 2000, 2200/3 recall (Z-1955-2009) | Draeger Medical Systems, Inc. | 2009-08-25 |
| Draeger Medical Apollo Anesthesia Machine, catalog number 8606500 recall (Z-0087-2009) | Draeger Medical, Inc. | 2008-10-08 |