EIM-107 PREP-CHECK— 510(k) K993202

Substantially Equivalent

General Devices

FDA 510(k) clearance K993202 for EIM-107 PREP-CHECK, Substantially Equivalent on 1999-12-17. Applicant: General Devices. Device class: 2.

Clearance details

Applicant: General Devices
Product code: Code GZO
Device class: Class 2
Regulation: 21 CFR 882.1540
Advisory panel: Neurology
Date received: 1999-09-24
Decision date: 1999-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ridgefield, NJ, US

Download summary PDF View on FDA.gov ↗

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