K890795 is an FDA 510(k) clearance for the RESPIRONICS SEALEASY II. This device is classified as a Mask, Gas, Anesthetic (Class I - General Controls, product code BSJ).
Submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on April 20, 1989, 62 days after receiving the submission on February 17, 1989.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5550.
| 510(k) Number | K890795 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 17, 1989 |
| Decision Date | April 20, 1989 |
| Days to Decision | 62 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | BSJ — Mask, Gas, Anesthetic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5550 |