SPACE(TM) 7500— 510(k) K912071

Substantially Equivalent

F.M. Wiest USA, Inc.

FDA 510(k) clearance K912071 for SPACE(TM) 7500, Substantially Equivalent on 1991-07-09. Applicant: F.M. Wiest USA, Inc.. Device class: 2.

Clearance details

Applicant: F.M. Wiest USA, Inc.
Product code: Code IKN
Device class: Class 2
Regulation: 21 CFR 890.1375
Advisory panel: Physical Medicine
Date received: 1991-05-10
Decision date: 1991-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oradell, NJ, US

Download summary PDF View on FDA.gov ↗

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