ISOSTATION ANKLE/SUBTALAR MACHINE A-100— 510(k) K844060

Name: FDA 510(k) clearance K844060
Creator: U.S. Food and Drug Administration
Published: 1984-11-23

Substantially Equivalent

Isotechnologies, Inc.

FDA 510(k) clearance K844060 for ISOSTATION ANKLE/SUBTALAR MACHINE A-100, Substantially Equivalent on 1984-11-23. Applicant: Isotechnologies, Inc.. Device class: 2.

Clearance details

Applicant: Isotechnologies, Inc.
Product code: Code IKK
Device class: Class 2
Regulation: 21 CFR 890.1925
Advisory panel: Physical Medicine
Date received: 1984-10-18
Decision date: 1984-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hillsborough, NC, US

Download summary PDF View on FDA.gov ↗

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