RESUSCITAIRE WITH AUTOBREATH
FDA 510(k) clearance K120642 · decided 2012-11-02
Clearance details
- K-number
- K120642
- Device name
- RESUSCITAIRE WITH AUTOBREATH
- Applicant
- Draeger Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-03-02
- Decision date
- 2012-11-02
- Days to decision
- 245 days
- Clearance type
- Traditional
- Product code
- FMT
- Device class
- 2
- Regulation number
- 880.5130
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Telford, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Draeger Softbed Resuscitaire and/or Birthing Room Warmer with Scale [Model(s): RW82VHA-1, recall (Z-1992-2023) | Draeger Medical Systems, Inc. | 2023-06-22 |