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FDA 510(k)

CARDIO2 CYCLE

K-Number: K926233 · 1993-06-04

ApplicantErgometrix, Inc.
Decision Date1993-06-04
Product CodeKRI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIO2 CYCLE is the device name listed in this FDA 510(k) record. The listed applicant is Ergometrix, Inc.. It received FDA 510(k) clearance on 1993-06-04 under 510(k) number K926233. The device is classified under product code KRI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIO2 CYCLE?

CARDIO2 CYCLE is a medical device that received FDA 510(k) clearance on 1993-06-04. The listed applicant is Ergometrix, Inc.. The 510(k) number is K926233.

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

CARDIO2 CYCLE received FDA 510(k) clearance on 1993-06-04, under 510(k) number K926233.

Who is the listed applicant for CARDIO2 CYCLE?

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

What is the FDA product code for CARDIO2 CYCLE?

The FDA product code for CARDIO2 CYCLE is KRI.

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Related Devices (Code: KRI)

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

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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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