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FDA 510(k)

CAMBRIDGE PC/GXT STRESS TEST SYSTEM

K-Number: K921331 · 1992-05-11

ApplicantHealth Watch, Inc.
Decision Date1992-05-11
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CAMBRIDGE PC/GXT STRESS TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Health Watch, Inc.. It received FDA 510(k) clearance on 1992-05-11 under 510(k) number K921331. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAMBRIDGE PC/GXT STRESS TEST SYSTEM?

CAMBRIDGE PC/GXT STRESS TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1992-05-11. The listed applicant is Health Watch, Inc.. The 510(k) number is K921331.

When did CAMBRIDGE PC/GXT STRESS TEST SYSTEM receive FDA 510(k) clearance?

CAMBRIDGE PC/GXT STRESS TEST SYSTEM received FDA 510(k) clearance on 1992-05-11, under 510(k) number K921331.

Who is the listed applicant for CAMBRIDGE PC/GXT STRESS TEST SYSTEM?

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

What is the FDA product code for CAMBRIDGE PC/GXT STRESS TEST SYSTEM?

The FDA product code for CAMBRIDGE PC/GXT STRESS TEST SYSTEM is DPS.

Related Clinical Trials

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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Other records listing Health Watch, Inc. as applicant

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.

K963136PACER MODEL 100 INFUSION CONTROLLER

Related Devices (Code: DPS)

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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