Aerobica - Lung Exerciser

FDA 510(k) K873540 · MBA Healthcare Products, Inc.

Substantially Equivalent

510(k) numberK873540

Submission

Device name
Aerobica - Lung Exerciser
Applicant
MBA Healthcare Products, Inc.
Fayetteville, NY, US
Received
September 1, 1987
Decision date
February 4, 1988
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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K222018Breathe+BWF · Traditional Peep Medical, LLC Dba Go2 Devices06/02/2023SE
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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
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More from Teleflexmedical, Inc.

510(k)DeviceDecision
K871904Total Lung Exerciser (Tle)BWF · Traditional 07/08/1987SE

Questions and answers

When was Aerobica - Lung Exerciser cleared by the FDA?

Aerobica - Lung Exerciser (K873540) received a 510(k) decision of Substantially Equivalent on February 4, 1988, 156 days after the submission was received.

What is the product code of K873540?

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