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FDA 510(k)

COORDINATOR

K-Number: K895113 · 1989-10-26

ApplicantCardiotronics, Inc.
Decision Date1989-10-26
Product CodeLDD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COORDINATOR is the device name listed in this FDA 510(k) record. The listed applicant is Cardiotronics, Inc.. It received FDA 510(k) clearance on 1989-10-26 under 510(k) number K895113. The device is classified under product code LDD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COORDINATOR?

COORDINATOR is a medical device that received FDA 510(k) clearance on 1989-10-26. The listed applicant is Cardiotronics, Inc.. The 510(k) number is K895113.

When did COORDINATOR receive FDA 510(k) clearance?

COORDINATOR received FDA 510(k) clearance on 1989-10-26, under 510(k) number K895113.

Who is the listed applicant for COORDINATOR?

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 COORDINATOR?

The FDA product code for COORDINATOR is LDD.

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Other records listing Cardiotronics, Inc. as applicant

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Related Devices (Code: LDD)

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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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