K863172 is an FDA 510(k) clearance for the RESPIRONICS PTL REVIVEEASY. This device is classified as a Airway, Esophageal (obturator) (Class II - Special Controls, product code CAO).
Submitted by Respironics, Inc. (Monroeville, US). The FDA issued a Cleared decision on November 4, 1986, 78 days after receiving the submission on August 18, 1986.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5650.
| 510(k) Number | K863172 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 18, 1986 |
| Decision Date | November 04, 1986 |
| Days to Decision | 78 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | CAO — Airway, Esophageal (obturator) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5650 |