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FDA 510(k)

QUEST EXERCISE STRESS SYSTEM (QUEST), VERSION 3.52

K-Number: K021097 · 2002-06-28

ApplicantSpacelabs Medical, Inc.
Decision Date2002-06-28
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

QUEST EXERCISE STRESS SYSTEM (QUEST), VERSION 3.52 is the device name listed in this FDA 510(k) record. The listed applicant is Spacelabs Medical, Inc.. It received FDA 510(k) clearance on 2002-06-28 under 510(k) number K021097. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUEST EXERCISE STRESS SYSTEM (QUEST), VERSION 3.52?

QUEST EXERCISE STRESS SYSTEM (QUEST), VERSION 3.52 is a medical device that received FDA 510(k) clearance on 2002-06-28. The listed applicant is Spacelabs Medical, Inc.. The 510(k) number is K021097.

When did QUEST EXERCISE STRESS SYSTEM (QUEST), VERSION 3.52 receive FDA 510(k) clearance?

QUEST EXERCISE STRESS SYSTEM (QUEST), VERSION 3.52 received FDA 510(k) clearance on 2002-06-28, under 510(k) number K021097.

Who is the listed applicant for QUEST EXERCISE STRESS SYSTEM (QUEST), VERSION 3.52?

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

What is the FDA product code for QUEST EXERCISE STRESS SYSTEM (QUEST), VERSION 3.52?

The FDA product code for QUEST EXERCISE STRESS SYSTEM (QUEST), VERSION 3.52 is DSI.

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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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