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FDA 510(k)

RESPIRATORY GAS ANALYZER

K-Number: K823449 · 1983-01-05

ApplicantThoratec Laboratories Corp.
Decision Date1983-01-05
Product CodeCCL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RESPIRATORY GAS ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Thoratec Laboratories Corp.. It received FDA 510(k) clearance on 1983-01-05 under 510(k) number K823449. The device is classified under product code CCL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESPIRATORY GAS ANALYZER?

RESPIRATORY GAS ANALYZER is a medical device that received FDA 510(k) clearance on 1983-01-05. The listed applicant is Thoratec Laboratories Corp.. The 510(k) number is K823449.

When did RESPIRATORY GAS ANALYZER receive FDA 510(k) clearance?

RESPIRATORY GAS ANALYZER received FDA 510(k) clearance on 1983-01-05, under 510(k) number K823449.

Who is the listed applicant for RESPIRATORY GAS ANALYZER?

The FDA 510(k) record lists Thoratec Laboratories Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RESPIRATORY GAS ANALYZER?

The FDA product code for RESPIRATORY GAS ANALYZER is CCL.

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Other records listing Thoratec Laboratories Corp. 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.

K001927VECTRA (TM) VASCULAR ACCESS GRAFT-5MM DIAMETER,6MM DIAMETER AND VECTRA (TM) VASCULAR ACCESS GRAFT FOR REVISION-5MM DIAMEK001926VASCULAR GRAFT TUNNELER-STANDARD CURVE, MID CURVE, FULL CURVE, SHORT STANDARD CURVE, VASCULAR GRAFT TUNNELER ACCESSORIESK851495THORATEC MULTILUMEN CENTRAL VENOUS CATH-TRAYK833714RESPIRATORY ASSESSMENT SYSTEMK833265RESPIRATORY FLOW MODULEK831557INTRAOPERATIVE AUTOTRANSFUSION SYS

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Related Devices (Code: CCL)

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.

K261389PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)Salter LabsK251245OxyMinder Pro (10310)Bio-Med Device, Inc.K250002Smart Check O2 (MA0236)Life Spark Medical, LLCK221734Maxtec MaxO2 ME+pMaxtec, LLCK213933Percent Oxygen SensorsCareox, LLCK213948OxyMinderBio-Med Devices, Inc.

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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