K880450 is an FDA 510(k) clearance for the RESUSCI PATIENT FACE SHIELD. This device is classified as a Ventilator, Emergency, Manual (resuscitator) (Class II — Special Controls, product code BTM).
Submitted by Laerdal Medical Corp. (Armonk, US). The FDA issued a Cleared decision on March 4, 1988, 31 days after receiving the submission on February 2, 1988.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5915.
| 510(k) Number | K880450 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent — Traditional 510(k) (SESE) |
| Date Received | February 02, 1988 |
| Decision Date | March 04, 1988 |
| Days to Decision | 31 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | BTM — Ventilator, Emergency, Manual (resuscitator) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.5915 |