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FDA 510(k)

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

K-Number: K883523 · 1988-10-06

ApplicantCardiotronics, Inc.
Decision Date1988-10-06
Product CodeDRO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TRIAD-EP, PUSHBUTTON, CABLE INPUT TYPE, W/PULSE is the device name listed in this FDA 510(k) record. The listed applicant is Cardiotronics, Inc.. It received FDA 510(k) clearance on 1988-10-06 under 510(k) number K883523. The device is classified under product code DRO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRIAD-EP, PUSHBUTTON, CABLE INPUT TYPE, W/PULSE?

TRIAD-EP, PUSHBUTTON, CABLE INPUT TYPE, W/PULSE is a medical device that received FDA 510(k) clearance on 1988-10-06. The listed applicant is Cardiotronics, Inc.. The 510(k) number is K883523.

When did TRIAD-EP, PUSHBUTTON, CABLE INPUT TYPE, W/PULSE receive FDA 510(k) clearance?

TRIAD-EP, PUSHBUTTON, CABLE INPUT TYPE, W/PULSE received FDA 510(k) clearance on 1988-10-06, under 510(k) number K883523.

Who is the listed applicant for TRIAD-EP, PUSHBUTTON, CABLE INPUT TYPE, W/PULSE?

The FDA 510(k) record lists Cardiotronics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRIAD-EP, PUSHBUTTON, CABLE INPUT TYPE, W/PULSE?

The FDA product code for TRIAD-EP, PUSHBUTTON, CABLE INPUT TYPE, W/PULSE is DRO.

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Related Devices (Code: DRO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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