INTRASCAN II— 510(k) K944771

Substantially Equivalent

Markcare Medical Systems, Inc.

FDA 510(k) clearance K944771 for INTRASCAN II, Substantially Equivalent on 1995-01-26. Applicant: Markcare Medical Systems, Inc.. Device class: 1.

Clearance details

Applicant: Markcare Medical Systems, Inc.
Product code: Code LMD
Device class: Class 1
Regulation: 21 CFR 892.2020
Advisory panel: Radiology
Date received: 1994-09-27
Decision date: 1995-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maywood, NJ, US

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