TECHNOMED C-SCAN COLOR ELLIPSOID TOPOMETER— 510(k) K945382

Name: FDA 510(k) clearance K945382
Creator: U.S. Food and Drug Administration
Published: 1995-01-31

Substantially Equivalent

Expertech Assoc., Inc.

FDA 510(k) clearance K945382 for TECHNOMED C-SCAN COLOR ELLIPSOID TOPOMETER, Substantially Equivalent on 1995-01-31. Applicant: Expertech Assoc., Inc.. Device class: 1.

Clearance details

Applicant: Expertech Assoc., Inc.
Product code: Code HLQ
Device class: Class 1
Regulation: 21 CFR 886.1350
Advisory panel: Ophthalmic
Date received: 1994-11-02
Decision date: 1995-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, MA, US

Download summary PDF View on FDA.gov ↗

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