EVIS 140 SYSTEM

Endoscopic Video Imaging System/component, Gastroenterology-urology

OLYMPUS AMERICA, INC.

The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Evis 140 System.

Pre-market Notification Details

• Device ID: K954451
• 510k Number: K954451
• Device Name: EVIS 140 SYSTEM
• Classification: Endoscopic Video Imaging System/component, Gastroenterology-urology
• Applicant: OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157
• Contact: Barry E Sanda
• Correspondent: Barry E Sanda; OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157
• Product Code: FET
• CFR Regulation Number: 876.1500 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-09-25
• Decision Date: 1996-03-29
• Summary: summary

NIH GUDID Devices

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