TECA PREMIERE— 510(k) K953732
Substantially EquivalentMedelec , Ltd.
FDA 510(k) clearance K953732 for TECA PREMIERE, Substantially Equivalent on 1995-10-19. Applicant: Medelec , Ltd.. Device class: 2.
Clearance details
- Applicant
- Medelec , Ltd.
- Product code
- Code GWJ
- Device class
- Class 2
- Regulation
- 21 CFR 882.1900
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Old Woking, Surrey, DE
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