K041568 is an FDA 510(k) clearance for the EOCD. This device is classified as a Conserver, Oxygen (Class II - Special Controls, product code NFB).
Submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on July 21, 2004, 41 days after receiving the submission on June 10, 2004.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5905.
| 510(k) Number | K041568 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 10, 2004 |
| Decision Date | July 21, 2004 |
| Days to Decision | 41 days |
| Submission Type | Abbreviated |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | NFB — Conserver, Oxygen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5905 |