ODFS PACE— 510(k) K102115

Substantially Equivalent

Odstock Medical, Ltd.

FDA 510(k) clearance K102115 for ODFS PACE, Substantially Equivalent on 2011-03-30. Applicant: Odstock Medical, Ltd.. Device class: 2.

Clearance details

Applicant: Odstock Medical, Ltd.
Product code: Code GZI
Device class: Class 2
Regulation: 21 CFR 882.5810
Advisory panel: Neurology
Date received: 2010-07-28
Decision date: 2011-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salisbury, Wiltshire, GB

Download summary PDF View on FDA.gov ↗

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