K812564 is an FDA 510(k) clearance for the ZEE LIFE SUPPORT AIR PANTS. This device is classified as a Trousers, Anti-shock (Class II - Special Controls, product code LHX).
Submitted by Zee Medical Products Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on October 23, 1981, 45 days after receiving the submission on September 8, 1981.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.5800.
| 510(k) Number | K812564 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 08, 1981 |
| Decision Date | October 23, 1981 |
| Days to Decision | 45 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | LHX — Trousers, Anti-shock |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5800 |