BAXTER ADULT/PEDI/INFANT SINGLE USE MAN RESUSCIT
FDA 510(k) clearance K924610 · decided 1993-04-06
Clearance details
- K-number
- K924610
- Device name
- BAXTER ADULT/PEDI/INFANT SINGLE USE MAN RESUSCIT
- Applicant
- Engineered Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 1992-09-11
- Decision date
- 1993-04-06
- Days to decision
- 207 days
- Clearance type
- Traditional
- Product code
- BTM
- Device class
- 2
- Regulation number
- 868.5915
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 1) Adult Manual Resuscitator, 2K8004, Oxygen Reservoir Bag, Adult Mask; 2) Adult Manual Re recall (Z-1947-2013) | Carefusion 2200 Inc | 2013-08-13 |