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FDA 510(k)

QUEST EXERCISE STRESS SYSTEM, MODEL CONFIGURATION 14

K-Number: K011339 · 2001-08-20

ApplicantSpacelabs Burdick, Inc.
Decision Date2001-08-20
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

QUEST EXERCISE STRESS SYSTEM, MODEL CONFIGURATION 14 is the device name listed in this FDA 510(k) record. The listed applicant is Spacelabs Burdick, Inc.. It received FDA 510(k) clearance on 2001-08-20 under 510(k) number K011339. 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, MODEL CONFIGURATION 14?

QUEST EXERCISE STRESS SYSTEM, MODEL CONFIGURATION 14 is a medical device that received FDA 510(k) clearance on 2001-08-20. The listed applicant is Spacelabs Burdick, Inc.. The 510(k) number is K011339.

When did QUEST EXERCISE STRESS SYSTEM, MODEL CONFIGURATION 14 receive FDA 510(k) clearance?

QUEST EXERCISE STRESS SYSTEM, MODEL CONFIGURATION 14 received FDA 510(k) clearance on 2001-08-20, under 510(k) number K011339.

Who is the listed applicant for QUEST EXERCISE STRESS SYSTEM, MODEL CONFIGURATION 14?

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

What is the FDA product code for QUEST EXERCISE STRESS SYSTEM, MODEL CONFIGURATION 14?

The FDA product code for QUEST EXERCISE STRESS SYSTEM, MODEL CONFIGURATION 14 is DSI.

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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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