TOPOGRAPHIC MODELING SYSTEM 2 TMS-2— 510(k) K944207

Name: FDA 510(k) clearance K944207
Creator: U.S. Food and Drug Administration
Published: 1994-12-07

Substantially Equivalent

Computed Anatomy, Inc.

FDA 510(k) clearance K944207 for TOPOGRAPHIC MODELING SYSTEM 2 TMS-2, Substantially Equivalent on 1994-12-07. Applicant: Computed Anatomy, Inc.. Device class: 1.

Clearance details

Applicant: Computed Anatomy, Inc.
Product code: Code HLQ
Device class: Class 1
Regulation: 21 CFR 886.1350
Advisory panel: Ophthalmic
Date received: 1994-08-29
Decision date: 1994-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

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