K022650 is an FDA 510(k) clearance for the APEX MEDICAL CPAP RT 21XX. This device is classified as a Ventilator, Non-continuous (respirator) (Class II - Special Controls, product code BZD).
Submitted by Apex Medical Corp. (Shi-Chih, Taipei Hsien, TW). The FDA issued a Cleared decision on February 4, 2004, 544 days after receiving the submission on August 9, 2002.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5905.
| 510(k) Number | K022650 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 09, 2002 |
| Decision Date | February 04, 2004 |
| Days to Decision | 544 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | BZD — Ventilator, Non-continuous (respirator) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5905 |