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FDA 510(k)

SYSTEM 82 COMPUTERIZED LUNG VO. SPIRO

K-Number: K801918 · 1980-10-03

ApplicantPulmonary Testing Systems
Decision Date1980-10-03
Product CodeBZC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SYSTEM 82 COMPUTERIZED LUNG VO. SPIRO is the device name listed in this FDA 510(k) record. The listed applicant is Pulmonary Testing Systems. It received FDA 510(k) clearance on 1980-10-03 under 510(k) number K801918. 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 SYSTEM 82 COMPUTERIZED LUNG VO. SPIRO?

SYSTEM 82 COMPUTERIZED LUNG VO. SPIRO is a medical device that received FDA 510(k) clearance on 1980-10-03. The listed applicant is Pulmonary Testing Systems. The 510(k) number is K801918.

When did SYSTEM 82 COMPUTERIZED LUNG VO. SPIRO receive FDA 510(k) clearance?

SYSTEM 82 COMPUTERIZED LUNG VO. SPIRO received FDA 510(k) clearance on 1980-10-03, under 510(k) number K801918.

Who is the listed applicant for SYSTEM 82 COMPUTERIZED LUNG VO. SPIRO?

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

What is the FDA product code for SYSTEM 82 COMPUTERIZED LUNG VO. SPIRO?

The FDA product code for SYSTEM 82 COMPUTERIZED LUNG VO. SPIRO 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Pulmonary Testing Systems 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.

K801919SYSTEM 88 COMPUTERIZED DIFFUSION ANALYK801920SYSTEM 80 COMPUTERIZED SPIROMETER

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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