COLORPOINT OR PROFESSIONAL COLORPOINT— 510(k) K971760

Name: FDA 510(k) clearance K971760
Creator: U.S. Food and Drug Administration
Published: 1997-10-01

Substantially Equivalent

Seiko Instruments USA, Inc.

FDA 510(k) clearance K971760 for COLORPOINT OR PROFESSIONAL COLORPOINT, Substantially Equivalent on 1997-10-01. Applicant: Seiko Instruments USA, Inc.. Device class: 2.

Clearance details

Applicant: Seiko Instruments USA, Inc.
Product code: Code LMC
Device class: Class 2
Regulation: 21 CFR 892.2040
Advisory panel: Radiology
Date received: 1997-05-12
Decision date: 1997-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chiba-Ken, JP

Download summary PDF View on FDA.gov ↗

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