K062664 is an FDA 510(k) clearance for the HUMIDCARE HEATED HUMIDIFIER, MODEL 9S-004. This device is classified as a Humidifier, Respiratory Gas, (direct Patient Interface) (Class II - Special Controls, product code BTT).
Submitted by Apex Medical Corp. (Tucheng City, Taipei County, TW). The FDA issued a Cleared decision on December 6, 2006, 90 days after receiving the submission on September 7, 2006.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5450.
| 510(k) Number | K062664 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 07, 2006 |
| Decision Date | December 06, 2006 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | BTT — Humidifier, Respiratory Gas, (direct Patient Interface) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5450 |