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FDA 510(k)

CARDIO 500

K-Number: K913754 · 1991-10-21

ApplicantKontron Elektronik GmbH
Decision Date1991-10-21
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CARDIO 500 is the device name listed in this FDA 510(k) record. The listed applicant is Kontron Elektronik GmbH. It received FDA 510(k) clearance on 1991-10-21 under 510(k) number K913754. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIO 500?

CARDIO 500 is a medical device that received FDA 510(k) clearance on 1991-10-21. The listed applicant is Kontron Elektronik GmbH. The 510(k) number is K913754.

When did CARDIO 500 receive FDA 510(k) clearance?

CARDIO 500 received FDA 510(k) clearance on 1991-10-21, under 510(k) number K913754.

Who is the listed applicant for CARDIO 500?

The FDA 510(k) record lists Kontron Elektronik GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARDIO 500?

The FDA product code for CARDIO 500 is LLZ.

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Official Source

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

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