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FDA 510(k)

AUTOMATED PULMONARY FUNCTION LABORATORY

K-Number: K803255 · 1981-01-28

ApplicantCardio Pulmonary Instruments
Decision Date1981-01-28
Product CodeBZC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AUTOMATED PULMONARY FUNCTION LABORATORY is the device name listed in this FDA 510(k) record. The listed applicant is Cardio Pulmonary Instruments. It received FDA 510(k) clearance on 1981-01-28 under 510(k) number K803255. 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 AUTOMATED PULMONARY FUNCTION LABORATORY?

AUTOMATED PULMONARY FUNCTION LABORATORY is a medical device that received FDA 510(k) clearance on 1981-01-28. The listed applicant is Cardio Pulmonary Instruments. The 510(k) number is K803255.

When did AUTOMATED PULMONARY FUNCTION LABORATORY receive FDA 510(k) clearance?

AUTOMATED PULMONARY FUNCTION LABORATORY received FDA 510(k) clearance on 1981-01-28, under 510(k) number K803255.

Who is the listed applicant for AUTOMATED PULMONARY FUNCTION LABORATORY?

The FDA 510(k) record lists Cardio Pulmonary Instruments as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTOMATED PULMONARY FUNCTION LABORATORY?

The FDA product code for AUTOMATED PULMONARY FUNCTION LABORATORY is BZC.

Related Clinical Trials

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.

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Other records listing Cardio Pulmonary Instruments 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.

K810243SYSTEM 86 COMPUTERIZED LUNG VOL. SPIROMEK810196SYSTEM 84 COMPUTERIZED LUNG VOL. SPIROM

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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