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FDA 510(k)

GEM-CRIT CHECK

K-Number: K871686 · 1987-06-18

ApplicantDiamond Sensor Systems
Decision Date1987-06-18
Product CodeDRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GEM-CRIT CHECK is the device name listed in this FDA 510(k) record. The listed applicant is Diamond Sensor Systems. It received FDA 510(k) clearance on 1987-06-18 under 510(k) number K871686. The device is classified under product code DRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GEM-CRIT CHECK?

GEM-CRIT CHECK is a medical device that received FDA 510(k) clearance on 1987-06-18. The listed applicant is Diamond Sensor Systems. The 510(k) number is K871686.

When did GEM-CRIT CHECK receive FDA 510(k) clearance?

GEM-CRIT CHECK received FDA 510(k) clearance on 1987-06-18, under 510(k) number K871686.

Who is the listed applicant for GEM-CRIT CHECK?

The FDA 510(k) record lists Diamond Sensor Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GEM-CRIT CHECK?

The FDA product code for GEM-CRIT CHECK is DRY.

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 Diamond Sensor Systems 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.

K882450GEM-STAT W/COMP. GEM-STATPAK/GEM-CHECK & CRIT CHK.K873577GEM-STAT, GEM-PAK 2, GEM-CHECK, GEM-CRIT CHECK

Related Devices (Code: DRY)

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.

K234065CDI OneView Monitoring SystemTerumo Cardiovascular Systems CorporationK202154B-CaptaLivanova Deutschland, GmbHK202557Quantum Workstation 12 EliteSpectrum Medical , Ltd.K182110CDI Blood Parameter Monitoring System 550Terumo Cardiovascular Systems CorporationK181923Quantum Workstation 12.1Spectrum Medical , Ltd.K173591Quantum Diagnostic Module, Quantum Diagnostic Module - No GasSpectrum Medical , Ltd.

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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