Pep (Positive Expiratory Pressure) Therapy Device

FDA 510(k) K961077 · Healthscan Products, Inc.

Substantially Equivalent

510(k) numberK961077

Submission

Device name
Pep (Positive Expiratory Pressure) Therapy Device
Applicant
Healthscan Products, Inc.
Cedar Grove, NJ, US
Received
March 18, 1996
Decision date
July 15, 1996
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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

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More from Teleflexmedical, Inc.

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K962924Personal Best II with Zone Management SystemBZH · Traditional 10/25/1996SE
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Questions and answers

When was Pep (Positive Expiratory Pressure) Therapy Device cleared by the FDA?

Pep (Positive Expiratory Pressure) Therapy Device (K961077) received a 510(k) decision of Substantially Equivalent on July 15, 1996, 119 days after the submission was received.

What is the product code of K961077?

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