510(k) K201479
K201479 is an FDA 510(k) premarket notification submitted by Demetech Corporation for the device "DemeMASK". The FDA issued a decision of Substantially Equivalent on July 24, 2020. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Demetech Corporation has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 24, 2020
- Date Received
- June 4, 2020
- 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