TRIAD-EP II, PUSHBUTTON, CABLE INPUT
FDA 510(k) clearance K884532 · decided 1988-11-18
Clearance details
- K-number
- K884532
- Device name
- TRIAD-EP II, PUSHBUTTON, CABLE INPUT
- Applicant
- Cardiotronics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-10-28
- Decision date
- 1988-11-18
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- DRO
- Device class
- 2
- Regulation number
- 870.5550
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- West Carlsbad, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.