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FDA 510(k)

RESPIRATORY FLOW MODULE

K-Number: K833265 · 1983-11-28

ApplicantThoratec Laboratories Corp.
Decision Date1983-11-28
Product CodeJAX
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RESPIRATORY FLOW MODULE 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 1983-11-28 under 510(k) number K833265. The device is classified under product code JAX. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESPIRATORY FLOW MODULE?

RESPIRATORY FLOW MODULE is a medical device that received FDA 510(k) clearance on 1983-11-28. The listed applicant is Thoratec Laboratories Corp.. The 510(k) number is K833265.

When did RESPIRATORY FLOW MODULE receive FDA 510(k) clearance?

RESPIRATORY FLOW MODULE received FDA 510(k) clearance on 1983-11-28, under 510(k) number K833265.

Who is the listed applicant for RESPIRATORY FLOW MODULE?

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 FLOW MODULE?

The FDA product code for RESPIRATORY FLOW MODULE is JAX.

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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 SYSTEMK831557INTRAOPERATIVE AUTOTRANSFUSION SYSK823449RESPIRATORY GAS ANALYZER

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Related Devices (Code: JAX)

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.

K990962FLOSENSE, MODEL 29-8010Sdi Diagnostics, Inc.K921178PTI-A, PTI-P, PTI-N DISPOSABLE PNEUMOTACHSMedical Associated Services, Inc.K884464SPIROMETRICS MODEL 2200 SM200 FLOW SENSORSpirometrics, Inc.K853085PAX METERPeace Medical, Inc.K812825FLO-COR IBiotrine Corp.K791730RING-ORIFICE, TURBULENT FLOW PNEUMOTResearch Development Corp.

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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