Garment Electrodes— 510(k) K222863
Substantially EquivalentTone-A-Matic International, Inc.
FDA 510(k) clearance K222863 for Garment Electrodes, Substantially Equivalent on 2023-02-01. Applicant: Tone-A-Matic International, Inc.. Device class: 2.
Clearance details
- Applicant
- Tone-A-Matic International, Inc.
- Product code
- Code GXY
- Device class
- Class 2
- Regulation
- 21 CFR 882.1320
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mississauga, CA
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