HVT 2.0
FDA 510(k) clearance K221318 · decided 2022-12-13
Clearance details
- K-number
- K221318
- Device name
- HVT 2.0
- Applicant
- Vapotherm, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-05-06
- Decision date
- 2022-12-13
- Days to decision
- 221 days
- Clearance type
- Traditional
- Product code
- QAV
- Device class
- 2
- Regulation number
- 868.5454
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Exeter, NH, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| F&P Airvo 3 (K221338) | Fisher & Paykel Healthcare | 2023-01-27 |
| Precision Flow® HVNI (DEN170001) | Vapotherm, Inc. | 2018-04-10 |
Recalls involving this device
No recalls on record reference this clearance.