ODFS Pace XL— 510(k) K171396

Substantially Equivalent

Odstock Medical, Ltd.

FDA 510(k) clearance K171396 for ODFS Pace XL, Substantially Equivalent on 2018-01-31. 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: 2017-05-11
Decision date: 2018-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salisbury, 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.