DISCAM DIGITAL IMAGING SYSTEM— 510(k) K974535

Name: FDA 510(k) clearance K974535
Creator: U.S. Food and Drug Administration
Published: 1998-08-14

Substantially Equivalent

Marcher Enterprises, Ltd.

FDA 510(k) clearance K974535 for DISCAM DIGITAL IMAGING SYSTEM, Substantially Equivalent on 1998-08-14. Applicant: Marcher Enterprises, Ltd.. Device class: 2.

Clearance details

Applicant: Marcher Enterprises, Ltd.
Product code: Code HKI
Device class: Class 2
Regulation: 21 CFR 886.1120
Advisory panel: Ophthalmic
Date received: 1997-12-02
Decision date: 1998-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hereford, Herefordshire, GB

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