K940581 is an FDA 510(k) clearance for the BAGEASY(R) III CHILD/INFANT DISPOS MAN RESUSCITATORS. This device is classified as a Ventilator, Emergency, Manual (resuscitator) (Class II - Special Controls, product code BTM).
Submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on May 6, 1994, 87 days after receiving the submission on February 8, 1994.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5915.
| 510(k) Number | K940581 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 08, 1994 |
| Decision Date | May 06, 1994 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BTM — Ventilator, Emergency, Manual (resuscitator) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5915 |