510(k) K214094
K214094 is an FDA 510(k) premarket notification submitted by Roki Co., Ltd. for the device "ROKI Surgical Mask". The FDA issued a decision of Substantially Equivalent on Feb 24, 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
- Feb 24, 2022
- Date Received
- Dec 28, 2021
- Clearance Type
- Traditional
- 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)