LUMISCOPE MODEL 1000/APCC MODEL 1000— 510(k) K894127

Name: FDA 510(k) clearance K894127
Creator: U.S. Food and Drug Administration
Published: 1989-09-06

Substantially Equivalent

Lumiscope Co., Inc.

FDA 510(k) clearance K894127 for LUMISCOPE MODEL 1000/APCC MODEL 1000, Substantially Equivalent on 1989-09-06. Applicant: Lumiscope Co., Inc.. Device class: 2.

Clearance details

Applicant: Lumiscope Co., Inc.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 1989-06-12
Decision date: 1989-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edison, NJ, US

Download summary PDF View on FDA.gov ↗

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