510(k) K223738
K223738 is an FDA 510(k) premarket notification submitted by Coapt for the device "Alpha Control Liner System (ACLS)". The FDA issued a decision of Substantially Equivalent on January 11, 2023. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320. Coapt has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 11, 2023
- Date Received
- December 14, 2022
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Cutaneous
- Device Class
- Class II
- Regulation Number
- 882.1320
- Review Panel
- NE
- Submission Type