K893713 is an FDA 510(k) clearance for the NOVA OXYGEN TENT. This device is classified as a Tent, Oxygen (Class I - General Controls, product code BYL).
Submitted by Nova Health Systems, Inc. (Blackwood, US). The FDA issued a Cleared decision on August 21, 1989, 95 days after receiving the submission on May 18, 1989.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5700.
| 510(k) Number | K893713 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 18, 1989 |
| Decision Date | August 21, 1989 |
| Days to Decision | 95 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | BYL — Tent, Oxygen |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5700 |