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FDA 510(k)

CARDIO2 CTCKE

K-Number: K930253 · 1993-10-18

ApplicantErgometrx, Inc.
Decision Date1993-10-18
Product CodeISD
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

CARDIO2 CTCKE is the device name listed in this FDA 510(k) record. The listed applicant is Ergometrx, Inc.. It received FDA 510(k) clearance on 1993-10-18 under 510(k) number K930253. The device is classified under product code ISD. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIO2 CTCKE?

CARDIO2 CTCKE is a medical device that received FDA 510(k) clearance on 1993-10-18. The listed applicant is Ergometrx, Inc.. The 510(k) number is K930253.

When did CARDIO2 CTCKE receive FDA 510(k) clearance?

CARDIO2 CTCKE received FDA 510(k) clearance on 1993-10-18, under 510(k) number K930253.

Who is the listed applicant for CARDIO2 CTCKE?

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

What is the FDA product code for CARDIO2 CTCKE?

The FDA product code for CARDIO2 CTCKE is ISD.

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Related Devices (Code: ISD)

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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