BOBCAT DX— 510(k) K970543

Substantially Equivalent

Quest Enabling Designs , Ltd.

FDA 510(k) clearance K970543 for BOBCAT DX, Substantially Equivalent on 1997-06-26. Applicant: Quest Enabling Designs , Ltd.. Device class: 2.

Clearance details

Applicant: Quest Enabling Designs , Ltd.
Product code: Code IPL
Device class: Class 2
Regulation: 21 CFR 890.3900
Advisory panel: Physical Medicine
Date received: 1997-02-12
Decision date: 1997-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fareham, Hampshire, 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.