PEP (POSITIVE EXPIRATORY PRESSURE) THERAPY DEVICE— 510(k) K961077

Name: FDA 510(k) clearance K961077
Creator: U.S. Food and Drug Administration
Published: 1996-07-15

Substantially Equivalent

Healthscan Products, Inc.

FDA 510(k) clearance K961077 for PEP (POSITIVE EXPIRATORY PRESSURE) THERAPY DEVICE, Substantially Equivalent on 1996-07-15. Applicant: Healthscan Products, Inc.. Device class: 2.

Clearance details

Applicant: Healthscan Products, Inc.
Product code: Code BWF
Device class: Class 2
Regulation: 21 CFR 868.5690
Advisory panel: Anesthesiology
Date received: 1996-03-18
Decision date: 1996-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cedar Grove, NJ, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.