PRECISION FLOW(R) - HELIOX
FDA 510(k) clearance K111640 · decided 2011-10-07
Clearance details
- K-number
- K111640
- Device name
- PRECISION FLOW(R) - HELIOX
- Applicant
- Vapotherm, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-06-13
- Decision date
- 2011-10-07
- Days to decision
- 116 days
- Clearance type
- Traditional
- Product code
- BTT
- Device class
- 2
- Regulation number
- 868.5450
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Stevensville, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Low Flow Disposable Patient Circuit for the Precision Flow System, Product Code PF-DPC-LOW recall (Z-1272-2023) | Vapotherm | 2023-03-17 |