K833328 is an FDA 510(k) clearance for the RESPIRONICS RESCUE DOME. This device is classified as a Airway, Oropharyngeal, Anesthesiology (Class I - General Controls, product code CAE).
Submitted by Respironics, Inc. (Monroeville, US). The FDA issued a Cleared decision on December 16, 1983, 80 days after receiving the submission on September 27, 1983.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5110.
| 510(k) Number | K833328 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 1983 |
| Decision Date | December 16, 1983 |
| Days to Decision | 80 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | CAE — Airway, Oropharyngeal, Anesthesiology |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5110 |