510(k) K221724
K221724 is an FDA 510(k) premarket notification submitted by Tone-A-Matic International, Inc. for the device "Conductive Gel". The FDA issued a decision of Substantially Equivalent on September 23, 2022. The device falls under product code GYB (Media, Electroconductive), a Class II device regulated under 21 CFR 882.1275. Tone-A-Matic International, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 23, 2022
- Date Received
- June 14, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Media, Electroconductive
- Device Class
- Class II
- Regulation Number
- 882.1275
- Review Panel
- NE
- Submission Type