510(k) K222551
K222551 is an FDA 510(k) premarket notification submitted by Entreprise Premont, Inc. for the device "Humask Pro Vision, Humask Pro Vision 3000". The FDA issued a decision of Substantially Equivalent on Nov 10, 2022. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 10, 2022
- Date Received
- Aug 23, 2022
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mask, Surgical
- Device Class
- Class II
- Regulation Number
- 878.4040
- Review Panel
- HO
- Submission Type
- 510(k)