Mercury Expiratory Resistance Exerciser

FDA 510(k) K942919 · Mercury Ent., Inc. D/B/A Mercury Medical

Substantially Equivalent

510(k) numberK942919

Submission

Device name
Mercury Expiratory Resistance Exerciser
Applicant
Mercury Ent., Inc. D/B/A Mercury Medical
Clearwater, FL, US
Received
June 21, 1994
Decision date
September 19, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

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

Other 510(k)s with product code BWF

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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

Questions and answers

When was Mercury Expiratory Resistance Exerciser cleared by the FDA?

Mercury Expiratory Resistance Exerciser (K942919) received a 510(k) decision of Substantially Equivalent on September 19, 1994, 90 days after the submission was received.

What is the product code of K942919?

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