HANDHELD DYNAMOMETER, MODEL #160 AND #111— 510(k) K861396

Name: FDA 510(k) clearance K861396
Creator: U.S. Food and Drug Administration
Published: 1986-05-02

Substantially Equivalent

Spark Instruments & Academics, Inc.

FDA 510(k) clearance K861396 for HANDHELD DYNAMOMETER, MODEL #160 AND #111, Substantially Equivalent on 1986-05-02. Applicant: Spark Instruments & Academics, Inc.. Device class: 1.

Clearance details

Applicant: Spark Instruments & Academics, Inc.
Product code: Code HRW
Device class: Class 1
Regulation: 21 CFR 888.1250
Advisory panel: Orthopedic
Date received: 1986-04-15
Decision date: 1986-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Coralville, IA, US

Download summary PDF View on FDA.gov ↗

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