K925591 is an FDA 510(k) clearance for the MERIDIAN MEDICAL SYSTEMS HYPER INFLATION BAY SYST. This device is classified as a Mixer, Breathing Gases, Anesthesia Inhalation (Class II - Special Controls, product code BZR).
Submitted by Merit Medical Systems, Inc. (Indianapolis, US). The FDA issued a Cleared decision on September 16, 1993, 315 days after receiving the submission on November 5, 1992.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5330.
| 510(k) Number | K925591 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 05, 1992 |
| Decision Date | September 16, 1993 |
| Days to Decision | 315 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | BZR — Mixer, Breathing Gases, Anesthesia Inhalation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5330 |