DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921
FDA 510(k) clearance K052743 · decided 2005-12-22
Clearance details
- K-number
- K052743
- Device name
- DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921
- Applicant
- Dynarex Corp.
- Decision
- Substantially Equivalent
- Date received
- 2005-09-30
- Decision date
- 2005-12-22
- Days to decision
- 83 days
- Clearance type
- Traditional
- Product code
- CBP
- Device class
- 2
- Regulation number
- 868.5870
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Orangeburg, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CPR Shield With One Way Valve and Barrier Filter, Reorder No. 4921 --- Dynarex label, 100 recall (Z-2117-2014) | Dynarex Corporation | 2014-07-25 |