PFLEX EM(TM) (EXERCISE MONITOR)— 510(k) K864719

Name: FDA 510(k) clearance K864719
Creator: U.S. Food and Drug Administration
Published: 1987-03-16

Substantially Equivalent

Health Products, Inc.

FDA 510(k) clearance K864719 for PFLEX EM(TM) (EXERCISE MONITOR), Substantially Equivalent on 1987-03-16. Applicant: Health Products, Inc.. Device class: 2.

Clearance details

Applicant: Health Products, Inc.
Product code: Code BWF
Device class: Class 2
Regulation: 21 CFR 868.5690
Advisory panel: Anesthesiology
Date received: 1986-12-03
Decision date: 1987-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cedar Grove, NJ, US

Download summary PDF View on FDA.gov ↗

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