FDA 510(k)

OHIO VOLUME INCENTIVE SPIROMETER

K-Number: K813476 · 1981-12-31

Decision Date1981-12-31

Product CodeBWF

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

OHIO VOLUME INCENTIVE SPIROMETER is the device name listed in this FDA 510(k) record. The listed applicant is Airco/Ohio Medical Products. It received FDA 510(k) clearance on 1981-12-31 under 510(k) number K813476. The device is classified under product code BWF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OHIO VOLUME INCENTIVE SPIROMETER?

OHIO VOLUME INCENTIVE SPIROMETER is a medical device that received FDA 510(k) clearance on 1981-12-31. The listed applicant is Airco/Ohio Medical Products. The 510(k) number is K813476.

When did OHIO VOLUME INCENTIVE SPIROMETER receive FDA 510(k) clearance?

OHIO VOLUME INCENTIVE SPIROMETER received FDA 510(k) clearance on 1981-12-31, under 510(k) number K813476.

Who is the listed applicant for OHIO VOLUME INCENTIVE SPIROMETER?

The FDA 510(k) record lists Airco/Ohio Medical Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OHIO VOLUME INCENTIVE SPIROMETER?

The FDA product code for OHIO VOLUME INCENTIVE SPIROMETER is BWF.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Airco/Ohio Medical Products as applicant

K833459COAXIAL VOL. VENTILATOR CIRCUIT K833452OHIO GMS ABSORBER K832418OHIO TEMPERATURE SIMULATOR K832565OHIO 5400 VOLUME MONITOR K832185OHIO MODEL 922 SPIROMETER K830446OXYGEN MONITOR OHIO 5100

View all 13 devices →

Related Devices (Code: BWF)

K241152InSeeTidal Medical Technologies, LLC K233855AllPEPEnchant Tek Co. , Ltd.K221058LungTrainer (MD2 & MD3)Lung Trainers, LLC K222018Breathe+Peep Medical, LLC Dba Go2 Devices K220565Hudson RCI Triflo II Incentive Deep Breathing ExerciserMedline Industries, Inc.K203378PulsehalerRespinova, 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.