PRECISION FLOW
FDA 510(k) clearance K072845 · decided 2008-07-17
Clearance details
- K-number
- K072845
- Device name
- PRECISION FLOW
- Applicant
- Vapotherm, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-10-04
- Decision date
- 2008-07-17
- Days to decision
- 287 days
- Clearance type
- Traditional
- Product code
- BTT
- Device class
- 2
- Regulation number
- 868.5450
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Vapotherm
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.