510(k) K211315
K211315 is an FDA 510(k) premarket notification submitted by Pamel D.O.O for the device "Comby EEG Caps". The FDA issued a decision of Substantially Equivalent on Nov 9, 2021. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 9, 2021
- Date Received
- Apr 30, 2021
- Clearance Type
- Traditional
- 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
- 510(k)