ACU-TRAIN V (5)— 510(k) K920532

Name: FDA 510(k) clearance K920532
Creator: U.S. Food and Drug Administration
Published: 1992-07-17

Substantially Equivalent

Sterne Medical Equipment Div. Ontario , Ltd.

FDA 510(k) clearance K920532 for ACU-TRAIN V (5), Substantially Equivalent on 1992-07-17. Applicant: Sterne Medical Equipment Div. Ontario , Ltd.. Device class: 2.

Clearance details

Applicant: Sterne Medical Equipment Div. Ontario , Ltd.
Product code: Code IPF
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 1992-02-05
Decision date: 1992-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ontario L6w 1p4 Canada, CA

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.