510(k) K222351
K222351 is an FDA 510(k) premarket notification submitted by Vincent Healthcare Products Limited for the device "inspired VHB20 Heated Humidifier". The FDA issued a decision of Substantially Equivalent on December 21, 2022. The device falls under product code BTT (Humidifier, Respiratory Gas, (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5450. Vincent Healthcare Products Limited has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 21, 2022
- Date Received
- August 4, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Humidifier, Respiratory Gas, (Direct Patient Interface)
- Device Class
- Class II
- Regulation Number
- 868.5450
- Review Panel
- AN
- Submission Type