ORIMS DIGITAL ANGIOGRAPHY SYSTEM— 510(k) K952480

Name: FDA 510(k) clearance K952480
Creator: U.S. Food and Drug Administration
Published: 1995-08-25

Substantially Equivalent

Midwest Ophthalmic Instruments, Inc.

FDA 510(k) clearance K952480 for ORIMS DIGITAL ANGIOGRAPHY SYSTEM, Substantially Equivalent on 1995-08-25. Applicant: Midwest Ophthalmic Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Midwest Ophthalmic Instruments, Inc.
Product code: Code HKI
Device class: Class 2
Regulation: 21 CFR 886.1120
Advisory panel: Ophthalmic
Date received: 1995-05-30
Decision date: 1995-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Romeoville, IL, US

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