SPLITSCREEN (ME-975)— 510(k) K971153

Name: FDA 510(k) clearance K971153
Creator: U.S. Food and Drug Administration
Published: 1997-06-25

Substantially Equivalent

Merlin Engineering Works, Inc.

FDA 510(k) clearance K971153 for SPLITSCREEN (ME-975), Substantially Equivalent on 1997-06-25. Applicant: Merlin Engineering Works, Inc.. Device class: 1.

Clearance details

Applicant: Merlin Engineering Works, Inc.
Product code: Code LMD
Device class: Class 1
Regulation: 21 CFR 892.2020
Advisory panel: Radiology
Date received: 1997-03-28
Decision date: 1997-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palo Alto, CA, US

Download summary PDF View on FDA.gov ↗

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