Submission Details
| 510(k) Number | K223863 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 23, 2022 |
| Decision Date | October 13, 2023 |
| Days to Decision | 294 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
Cleared
Traditional
BONHAWA Respiratory Humidifier
Oct 2023
Decision
294d
Days
Class 2
Risk
About This 510(k) Submission
K223863 is an FDA 510(k) clearance for the BONHAWA Respiratory Humidifier, a Humidifier, Respiratory Gas, (direct Patient Interface) (Class II — Special Controls, product code BTT), submitted by Telesair, Inc. (Irvine, US). The FDA issued a Cleared decision on October 13, 2023, 294 days after receiving the submission on December 23, 2022. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5450.
Device Classification
| Product Code | BTT — Humidifier, Respiratory Gas, (direct Patient Interface) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.5450 |
Manufacturer
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