OSCAR, MODEL OE3000— 510(k) K021502

Substantially Equivalent

Orthosonics, Ltd.

FDA 510(k) clearance K021502 for OSCAR, MODEL OE3000, Substantially Equivalent on 2002-06-06. Applicant: Orthosonics, Ltd.. Device class: 2.

Clearance details

Applicant: Orthosonics, Ltd.
Product code: Code LZV
Device class: Class 2
Regulation: 21 CFR 888.4580
Advisory panel: Orthopedic
Date received: 2002-05-09
Decision date: 2002-06-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Brookeville, MD, US

Download summary PDF View on FDA.gov ↗

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