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FDA 510(k)

BUNN VOLUMAIRE RESPIRATORY EXERCISER

K-Number: K800546 · 1980-03-25

ApplicantThe John Bunn Co.
Decision Date1980-03-25
Product CodeBWF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BUNN VOLUMAIRE RESPIRATORY EXERCISER is the device name listed in this FDA 510(k) record. The listed applicant is The John Bunn Co.. It received FDA 510(k) clearance on 1980-03-25 under 510(k) number K800546. 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 BUNN VOLUMAIRE RESPIRATORY EXERCISER?

BUNN VOLUMAIRE RESPIRATORY EXERCISER is a medical device that received FDA 510(k) clearance on 1980-03-25. The listed applicant is The John Bunn Co.. The 510(k) number is K800546.

When did BUNN VOLUMAIRE RESPIRATORY EXERCISER receive FDA 510(k) clearance?

BUNN VOLUMAIRE RESPIRATORY EXERCISER received FDA 510(k) clearance on 1980-03-25, under 510(k) number K800546.

Who is the listed applicant for BUNN VOLUMAIRE RESPIRATORY EXERCISER?

The FDA 510(k) record lists The John Bunn Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BUNN VOLUMAIRE RESPIRATORY EXERCISER?

The FDA product code for BUNN VOLUMAIRE RESPIRATORY EXERCISER is BWF.

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Other records listing The John Bunn Co. 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.

K900854JOHN BUNN: MEDIX COMPACT TRAVELLERK883216BUNN MODEL 50 OXYGEN FLOW CONTROLLERK873071BUNN CONCENTRATOR MODEL 2100 SERIESK870094BUNN MODEL 530 ASPIRATORK861435BUNN CONCENTRATOR MODEL 2011 WITH DEMAND VALVEK861199BUNN MODEL 22 OXYGEN FLOW CONTROLLER

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Related Devices (Code: BWF)

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.

K241152InSeeTidal Medical Technologies, LLCK233855AllPEPEnchant Tek Co. , Ltd.K221058LungTrainer (MD2 & MD3)Lung Trainers, LLCK222018Breathe+Peep Medical, LLC Dba Go2 DevicesK220565Hudson 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.

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