K960401 is an FDA 510(k) clearance for the ULTIMATE SEAL. This device is classified as a Mask, Oxygen, Non-rebreathing (Class I - General Controls, product code KGB).
Submitted by Hans Rudolph, Inc. (Kansas City, US). The FDA issued a Cleared decision on June 20, 1996, 143 days after receiving the submission on January 29, 1996.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5570.
| 510(k) Number | K960401 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 29, 1996 |
| Decision Date | June 20, 1996 |
| Days to Decision | 143 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | KGB — Mask, Oxygen, Non-rebreathing |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5570 |