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FDA 510(k)

QUANTITATIVE SENTINEL SYSTEM

K-Number: K993008 · 1999-12-06

ApplicantMarquette Medical Systems, Inc.
Decision Date1999-12-06
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

QUANTITATIVE SENTINEL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Marquette Medical Systems, Inc.. It received FDA 510(k) clearance on 1999-12-06 under 510(k) number K993008. The device is classified under product code HGM. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTITATIVE SENTINEL SYSTEM?

QUANTITATIVE SENTINEL SYSTEM is a medical device that received FDA 510(k) clearance on 1999-12-06. The listed applicant is Marquette Medical Systems, Inc.. The 510(k) number is K993008.

When did QUANTITATIVE SENTINEL SYSTEM receive FDA 510(k) clearance?

QUANTITATIVE SENTINEL SYSTEM received FDA 510(k) clearance on 1999-12-06, under 510(k) number K993008.

Who is the listed applicant for QUANTITATIVE SENTINEL SYSTEM?

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

What is the FDA product code for QUANTITATIVE SENTINEL SYSTEM?

The FDA product code for QUANTITATIVE SENTINEL SYSTEM is HGM.

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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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