K863171 is an FDA 510(k) clearance for the RESPIRONICS PROTECTEASY. This device is classified as a Gas, Collecting Vessel (Class I - General Controls, product code KGK).
Submitted by Respironics, Inc. (Monroeville, US). The FDA issued a Cleared decision on October 15, 1986, 58 days after receiving the submission on August 18, 1986.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1575.
| 510(k) Number | K863171 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 18, 1986 |
| Decision Date | October 15, 1986 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | KGK — Gas, Collecting Vessel |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.1575 |