Atlas FDA

TRIAD-EP, PUSHBUTTON, CABLE INPUT TYPE, W/PULSE

FDA 510(k) clearance K883523 · decided 1988-10-06

Clearance details

K-number
K883523
Device name
TRIAD-EP, PUSHBUTTON, CABLE INPUT TYPE, W/PULSE
Applicant
Cardiotronics, Inc.
Decision
Substantially Equivalent
Date received
1988-08-17
Decision date
1988-10-06
Days to decision
50 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.