SMARTSCOPE— 510(k) K932533

Substantially Equivalent

Insight Medical Corp.

FDA 510(k) clearance K932533 for SMARTSCOPE, Substantially Equivalent on 1994-03-31. Applicant: Insight Medical Corp.. Device class: 2.

Clearance details

Applicant: Insight Medical Corp.
Product code: Code JXE
Device class: Class 2
Regulation: 21 CFR 882.1550
Advisory panel: Neurology
Date received: 1993-05-26
Decision date: 1994-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toronto, Ontario, CA

Download summary PDF View on FDA.gov ↗

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