PERSONAL BEST II WITH ZONE MANAGEMENT SYSTEM— 510(k) K962924

Name: FDA 510(k) clearance K962924
Creator: U.S. Food and Drug Administration
Published: 1996-10-25

Substantially Equivalent

Healthscan Products, Inc.

FDA 510(k) clearance K962924 for PERSONAL BEST II WITH ZONE MANAGEMENT SYSTEM, Substantially Equivalent on 1996-10-25. Applicant: Healthscan Products, Inc.. Device class: 2.

Clearance details

Applicant: Healthscan Products, Inc.
Product code: Code BZH
Device class: Class 2
Regulation: 21 CFR 868.1860
Advisory panel: Anesthesiology
Date received: 1996-07-29
Decision date: 1996-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cedar Grove, NJ, US

Download summary PDF View on FDA.gov ↗

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K962929 — PERSONAL BEST II1996-10-24
K962822 — OPTICHAMBER1996-10-17
K961077 — PEP (POSITIVE EXPIRATORY PRESSURE) THERAPY DEVICE1996-07-15
K933889 — PERSONAL BEST LOW RANGE1993-09-09

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