K932557 is an FDA 510(k) clearance for the HYPERINFLATION SYSTEM. This device is classified as a Mixer, Breathing Gases, Anesthesia Inhalation (Class II - Special Controls, product code BZR).
Submitted by Life Shield Healthcare Products, Inc. (Noblesville, US). The FDA issued a Cleared decision on July 22, 1993, 56 days after receiving the submission on May 27, 1993.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5330.
| 510(k) Number | K932557 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 27, 1993 |
| Decision Date | July 22, 1993 |
| Days to Decision | 56 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 |