Lung Function Amplifier Exerciser

FDA 510(k) K790744 · Empire Plastics Manufacturer

Substantially Equivalent

510(k) numberK790744

Submission

Device name
Lung Function Amplifier Exerciser
Applicant
Empire Plastics Manufacturer
Mchenry, IL, US
Received
April 16, 1979
Decision date
April 27, 1979
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
BWF – Spirometer, Therapeutic (Incentive)
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5690
Specialty
Anesthesiology

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K221058LungTrainer (MD2 & MD3)BWF · Traditional Lung Trainers, LLC07/05/2023SE
K222018Breathe+BWF · Traditional Peep Medical, LLC Dba Go2 Devices06/02/2023SE
K220565Hudson RCI Triflo II Incentive Deep Breathing ExerciserBWF · Traditional Medline Industries, Inc.10/25/2022SE
K203378PulsehalerBWF · Traditional Respinova, Ltd.03/31/2021SE
K192000D R Burton OxyPAPBWF · Traditional D R Burton Healthcare, LLC02/19/2020SE
K181660Acapella Choice Blue Vibratory PEP DeviceBWF · Traditional Smiths Medical10/24/2019SE
K183108Combined Aerobika OPEP and VersaPAP deviceBWF · Traditional Trudell Medical International08/16/2019SE
K182847Hudson RCI Voldyne Volumetric ExerciserBWF · Traditional Teleflexmedical, Inc.07/01/2019SE

More from Teleflexmedical, Inc.

510(k)DeviceDecision
K792573Alarm Used W/Monitoring SpirometerBZK · Traditional 12/31/1979SE
K792572Empire SpirometerBZK · Traditional 12/19/1979SE
K792571Counter UnitBWF · Traditional 12/19/1979SE

Questions and answers

When was Lung Function Amplifier Exerciser cleared by the FDA?

Lung Function Amplifier Exerciser (K790744) received a 510(k) decision of Substantially Equivalent on April 27, 1979, 11 days after the submission was received.

What is the product code of K790744?

The FDA product code is BWF – Spirometer, Therapeutic (Incentive), a Class II (moderate risk) device regulated under 21 CFR 868.5690.