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FDA 510(k)

PULMONARY FUNCTION TESTER, COMPUTERIZED

K-Number: K780328 · 1978-03-14

ApplicantWarren E. Collins, Inc.
Decision Date1978-03-14
Product CodeBZC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PULMONARY FUNCTION TESTER, COMPUTERIZED is the device name listed in this FDA 510(k) record. The listed applicant is Warren E. Collins, Inc.. It received FDA 510(k) clearance on 1978-03-14 under 510(k) number K780328. The device is classified under product code BZC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PULMONARY FUNCTION TESTER, COMPUTERIZED?

PULMONARY FUNCTION TESTER, COMPUTERIZED is a medical device that received FDA 510(k) clearance on 1978-03-14. The listed applicant is Warren E. Collins, Inc.. The 510(k) number is K780328.

When did PULMONARY FUNCTION TESTER, COMPUTERIZED receive FDA 510(k) clearance?

PULMONARY FUNCTION TESTER, COMPUTERIZED received FDA 510(k) clearance on 1978-03-14, under 510(k) number K780328.

Who is the listed applicant for PULMONARY FUNCTION TESTER, COMPUTERIZED?

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

What is the FDA product code for PULMONARY FUNCTION TESTER, COMPUTERIZED?

The FDA product code for PULMONARY FUNCTION TESTER, COMPUTERIZED is BZC.

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Other records listing Warren E. Collins, 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.

K925459GS-MODULAR (GOLD STANDARD - MODULAR)K912946COLLINS DIGITAL PULMONARY MANOMETERK871151THE SPIRA ELEKTRO 2K861227COLLINS PNEUMOTACH PFT SYSTEMK852102COLLIN BODY PLETHYSMOGRAPH PLUS SYSTEMK831780METABOLIC EXERCISE TESTING SYSTEM

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Related Devices (Code: BZC)

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.

K240293STSTechbopulm, Ltd.K183567Vyntus/SentrySuite Product LineVyaire MedicalK190853Vyntus BODYVyaire Medical, Inc.K181524Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CARTVyaire Medical, Inc.K162515COSMED K5 Wearable Metabolic TechnologyCosmed SrlK161295MiniBox +Pulmone Advanced Medical Devices, 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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