K070056 is an FDA 510(k) clearance for the VAPOTHERM MODEL# 2000I AND 2000H. This device is classified as a Humidifier, Respiratory Gas, (direct Patient Interface) (Class II - Special Controls, product code BTT).
Submitted by Vapotherm, Inc. (Washington, US). The FDA issued a Cleared decision on April 13, 2007, 98 days after receiving the submission on January 5, 2007.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5450.
| 510(k) Number | K070056 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 05, 2007 |
| Decision Date | April 13, 2007 |
| Days to Decision | 98 days |
| Submission Type | Special |
| 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 |