K063758 is an FDA 510(k) clearance for the CHONCHA THERM NEPTUNE HEATED HUMIFIER, CHONCHA THERM NEPTUNE HEATED HUMIFIER (REMANUFACTURER), MODEL# 425-00,425-00R. This device is classified as a Humidifier, Respiratory Gas, (direct Patient Interface) (Class II - Special Controls, product code BTT).
Submitted by Teleflex Medical (Bannockburn, US). The FDA issued a Cleared decision on April 23, 2007, 125 days after receiving the submission on December 19, 2006.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5450.
| 510(k) Number | K063758 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 2006 |
| Decision Date | April 23, 2007 |
| Days to Decision | 125 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BTT — Humidifier, Respiratory Gas, (direct Patient Interface) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5450 |