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FDA 510(k)

RESPIRATORY ASSESSMENT SYSTEM

K-Number: K833714 · 1983-12-29

ApplicantThoratec Laboratories Corp.
Decision Date1983-12-29
Product CodeBZL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RESPIRATORY ASSESSMENT SYSTEM 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 1983-12-29 under 510(k) number K833714. The device is classified under product code BZL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESPIRATORY ASSESSMENT SYSTEM?

RESPIRATORY ASSESSMENT SYSTEM is a medical device that received FDA 510(k) clearance on 1983-12-29. The listed applicant is Thoratec Laboratories Corp.. The 510(k) number is K833714.

When did RESPIRATORY ASSESSMENT SYSTEM receive FDA 510(k) clearance?

RESPIRATORY ASSESSMENT SYSTEM received FDA 510(k) clearance on 1983-12-29, under 510(k) number K833714.

Who is the listed applicant for RESPIRATORY ASSESSMENT SYSTEM?

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 ASSESSMENT SYSTEM?

The FDA product code for RESPIRATORY ASSESSMENT SYSTEM is BZL.

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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-TRAYK833265RESPIRATORY FLOW MODULEK831557INTRAOPERATIVE AUTOTRANSFUSION SYSK823449RESPIRATORY GAS ANALYZER

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Related Devices (Code: BZL)

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.

K200076Breezing MedTf Health Co.K190561NICU V'02Cosmed Nordic ApsK110810ANASCIENT BREATH MONITORInvoy Technologies, LLCK093080METAPHOR METABOLIC MONITORTreymed, Inc.K071533FITMATE SERIESCosmed SrlK070858EXPRESS SERIESMedical Graphics 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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