FDA 510(k)

ORCA CARDIOPULMONARY EXERCISE TESTING SYSTEM

K-Number: K974200 · 1998-07-21

Decision Date1998-07-21

Product CodeBZM

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

ORCA CARDIOPULMONARY EXERCISE TESTING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Orca Diagnostics Corp.. It received FDA 510(k) clearance on 1998-07-21 under 510(k) number K974200. The device is classified under product code BZM. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORCA CARDIOPULMONARY EXERCISE TESTING SYSTEM?

ORCA CARDIOPULMONARY EXERCISE TESTING SYSTEM is a medical device that received FDA 510(k) clearance on 1998-07-21. The listed applicant is Orca Diagnostics Corp.. The 510(k) number is K974200.

When did ORCA CARDIOPULMONARY EXERCISE TESTING SYSTEM receive FDA 510(k) clearance?

ORCA CARDIOPULMONARY EXERCISE TESTING SYSTEM received FDA 510(k) clearance on 1998-07-21, under 510(k) number K974200.

Who is the listed applicant for ORCA CARDIOPULMONARY EXERCISE TESTING SYSTEM?

The FDA 510(k) record lists Orca Diagnostics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORCA CARDIOPULMONARY EXERCISE TESTING SYSTEM?

The FDA product code for ORCA CARDIOPULMONARY EXERCISE TESTING SYSTEM is BZM.

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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.