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FDA 510(k)

LUNG FUNCTION AMPLIFIER EXERCISER

K-Number: K790744 · 1979-04-27

ApplicantEmpire Plastics Manufacturer
Decision Date1979-04-27
Product CodeBWF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

LUNG FUNCTION AMPLIFIER EXERCISER is the device name listed in this FDA 510(k) record. The listed applicant is Empire Plastics Manufacturer. It received FDA 510(k) clearance on 1979-04-27 under 510(k) number K790744. 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 LUNG FUNCTION AMPLIFIER EXERCISER?

LUNG FUNCTION AMPLIFIER EXERCISER is a medical device that received FDA 510(k) clearance on 1979-04-27. The listed applicant is Empire Plastics Manufacturer. The 510(k) number is K790744.

When did LUNG FUNCTION AMPLIFIER EXERCISER receive FDA 510(k) clearance?

LUNG FUNCTION AMPLIFIER EXERCISER received FDA 510(k) clearance on 1979-04-27, under 510(k) number K790744.

Who is the listed applicant for LUNG FUNCTION AMPLIFIER EXERCISER?

The FDA 510(k) record lists Empire Plastics Manufacturer as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LUNG FUNCTION AMPLIFIER EXERCISER?

The FDA product code for LUNG FUNCTION AMPLIFIER EXERCISER 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.

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Other records listing Empire Plastics Manufacturer 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.

K792573ALARM USED W/MONITORING SPIROMETERK792572EMPIRE SPIROMETERK792571COUNTER UNIT

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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