TRIAD-EP— 510(k) K880936
Substantially EquivalentCardiotronics, Inc.
FDA 510(k) clearance K880936 for TRIAD-EP, Substantially Equivalent on 1988-07-18. Applicant: Cardiotronics, Inc.. Device class: 2.
Clearance details
- Applicant
- Cardiotronics, Inc.
- Product code
- Code DRO
- Device class
- Class 2
- Regulation
- 21 CFR 870.5550
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Carlsbad, CA, US
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