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FDA 510(k)

QUANTITATIVE SENTINEL SYSTEM

K-Number: K963608 · 1997-03-11

ApplicantQuantitative Medicine, Inc.
Decision Date1997-03-11
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 Quantitative Medicine, Inc.. It received FDA 510(k) clearance on 1997-03-11 under 510(k) number K963608. 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 1997-03-11. The listed applicant is Quantitative Medicine, Inc.. The 510(k) number is K963608.

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

QUANTITATIVE SENTINEL SYSTEM received FDA 510(k) clearance on 1997-03-11, under 510(k) number K963608.

Who is the listed applicant for QUANTITATIVE SENTINEL SYSTEM?

The FDA 510(k) record lists Quantitative Medicine, 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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Other records listing Quantitative Medicine, 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.

K960109QUANTITATIVE SENTINEL SYSTEMK923255Q-SDK912462Q-MS NEUROMUSCULAR STIMULATORK912463MICRO-QK912460Q-TENSK904603QUANTIMETRIX QUAN TEST-RED PROTEIN ASSAY SYSTEM

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Related Devices (Code: HGM)

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

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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