K070609 is an FDA 510(k) clearance for the APEX MEDICAL XT1 CPAP, MODEL 9S-005. This device is classified as a Ventilator, Non-continuous (respirator) (Class II - Special Controls, product code BZD).
Submitted by Apex Medical Corp. (Tucheng City, Taipei County, TW). The FDA issued a Cleared decision on May 4, 2007, 60 days after receiving the submission on March 5, 2007.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5905.
| 510(k) Number | K070609 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 05, 2007 |
| Decision Date | May 04, 2007 |
| Days to Decision | 60 days |
| Submission Type | Special |
| 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 |