OSCAR, MODEL OE3000DB— 510(k) K051053

Substantially Equivalent

Orthosonics, Ltd.

FDA 510(k) clearance K051053 for OSCAR, MODEL OE3000DB, Substantially Equivalent on 2005-07-21. Applicant: Orthosonics, Ltd.. Device class: 2.

Clearance details

Applicant: Orthosonics, Ltd.
Product code: Code JDX
Device class: Class 2
Regulation: 21 CFR 888.4580
Advisory panel: Orthopedic
Date received: 2005-04-25
Decision date: 2005-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brookeville, MD, US

Download summary PDF View on FDA.gov ↗

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