K001742 is an FDA 510(k) clearance for the RESUSCI INFLATE-A-SHIELD CPR BARRIER. This device is classified as a Valve, Non-rebreathing (Class II - Special Controls, product code CBP).
Submitted by Laerdal Medical Corp. (North Attleboro, US). The FDA issued a Cleared decision on October 6, 2000, 120 days after receiving the submission on June 8, 2000.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5870.
| 510(k) Number | K001742 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 08, 2000 |
| Decision Date | October 06, 2000 |
| Days to Decision | 120 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CBP — Valve, Non-rebreathing |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5870 |