Counter OTC TENS Device, Model CSD-737Z— 510(k) K151279
Substantially EquivalentCounter Scientific Development (Gz), Ltd.
FDA 510(k) clearance K151279 for Counter OTC TENS Device, Model CSD-737Z, Substantially Equivalent on 2015-12-16. Applicant: Counter Scientific Development (Gz), Ltd.. Device class: 2.
Clearance details
- Applicant
- Counter Scientific Development (Gz), Ltd.
- Product code
- Code NUH
- Device class
- Class 2
- Regulation
- 21 CFR 882.5890
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Guangzhou, CN
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