CPR MASK
FDA 510(k) clearance K083418 · decided 2010-07-22
Clearance details
- K-number
- K083418
- Device name
- CPR MASK
- Applicant
- Firstar Healthcare Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2008-11-18
- Decision date
- 2010-07-22
- Days to decision
- 611 days
- Clearance type
- Traditional
- Product code
- CBP
- Device class
- 2
- Regulation number
- 868.5870
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Dover, DE, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Item # 4042-CPR Rescue Kit, containing CPR shield with one way valve & barrier filter. bra recall (Z-2132-2016) | Lifeline First Aid LLC | 2016-07-06 |
| 5195GM, Cadillac First Aid Kit, #23459698, brand General Motors. No UPC. recall (Z-2133-2016) | Lifeline First Aid LLC | 2016-07-06 |