Precision Flow® HVNI
FDA 510(k) clearance DEN170001 · decided 2018-04-10
Clearance details
- K-number
- DEN170001
- Device name
- Precision Flow® HVNI
- Applicant
- Vapotherm, Inc.
- Decision
- Unknown
- Date received
- 2017-01-03
- Decision date
- 2018-04-10
- Days to decision
- 462 days
- Clearance type
- Direct
- 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 |
| HVT 2.0 (K221318) | Vapotherm, Inc. | 2022-12-13 |
Recalls involving this device
No recalls on record reference this clearance.