K132021 is an FDA 510(k) clearance for the AHP 300, EMERGENCY PORTABLE VENTILATOR. This device is classified as a Ventilator, Emergency, Powered (resuscitator) (Class II - Special Controls, product code BTL).
Submitted by Allied Healthcare Products, Inc. (Saint Louis, US). The FDA issued a Cleared decision on April 2, 2014, 274 days after receiving the submission on July 2, 2013.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5925.
| 510(k) Number | K132021 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 02, 2013 |
| Decision Date | April 02, 2014 |
| Days to Decision | 274 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | BTL — Ventilator, Emergency, Powered (resuscitator) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5925 |