EVIS EXERA 160A SYSTEM

Endoscope, Accessories, Narrow Band Spectrum

OLYMPUS MEDICAL SYSTEMS CORPORATION

The following data is part of a premarket notification filed by Olympus Medical Systems Corporation with the FDA for Evis Exera 160a System.

Pre-market Notification Details

• Device ID: K051645
• 510k Number: K051645
• Device Name: EVIS EXERA 160A SYSTEM
• Classification: Endoscope, Accessories, Narrow Band Spectrum
• Applicant: OLYMPUS MEDICAL SYSTEMS CORPORATION TWO CORPORATE CENTER DR. Melville, NY 11747 -9058
• Contact: Laura Storms-tyler
• Correspondent: Laura Storms-tyler; OLYMPUS MEDICAL SYSTEMS CORPORATION TWO CORPORATE CENTER DR. Melville, NY 11747 -9058
• Product Code: NWB
• Subsequent Product Code: FDF
• Subsequent Product Code: FDS
• CFR Regulation Number: 876.1500 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-06-20
• Decision Date: 2005-10-13
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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