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FDA 510(k)

GAS-STAT MONITORING SYSTEM

K-Number: K831225 · 1983-05-27

ApplicantCardiovascular Devices, Inc.
Decision Date1983-05-27
Product CodeDRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GAS-STAT MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cardiovascular Devices, Inc.. It received FDA 510(k) clearance on 1983-05-27 under 510(k) number K831225. 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 GAS-STAT MONITORING SYSTEM?

GAS-STAT MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 1983-05-27. The listed applicant is Cardiovascular Devices, Inc.. The 510(k) number is K831225.

When did GAS-STAT MONITORING SYSTEM receive FDA 510(k) clearance?

GAS-STAT MONITORING SYSTEM received FDA 510(k) clearance on 1983-05-27, under 510(k) number K831225.

Who is the listed applicant for GAS-STAT MONITORING SYSTEM?

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

What is the FDA product code for GAS-STAT MONITORING SYSTEM?

The FDA product code for GAS-STAT MONITORING SYSTEM is DRY.

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Other records listing Cardiovascular Devices, 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.

K890113THE CDI(R) SYSTEM 400K884228CDI(R) 2000 BLOOD GAS MONITORK871221CDI(TM) EXTRACORPOREAL BLOOD GAS SYSTEM 300K864703MODIFIED GAS-STAT(TM) MONITORING SYSTEMK843912INTRAVASCULAR BLOOD GAS SYSTEMK840749GAST STAT MONITORING SYSTEM

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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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