CONVIVO

Endoscope, Neurological

Carl Zeiss Meditec AG

The following data is part of a premarket notification filed by Carl Zeiss Meditec Ag with the FDA for Convivo.

Pre-market Notification Details

• Device ID: K181116
• 510k Number: K181116
• Device Name: CONVIVO
• Classification: Endoscope, Neurological
• Applicant: Carl Zeiss Meditec AG Goeschwitzer Str. 51-52 Jena, DE 07745
• Contact: Christian Muenster
• Correspondent: Mandy Ambrecht; Carl Zeiss Meditec, Inc. 5160 Hacienda Drive Dublin, CA 94568
• Product Code: GWG
• CFR Regulation Number: 882.1480 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: Yes
• Date Received: 2018-04-27
• Decision Date: 2018-10-25
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04049539103413	K181116	000
04049539069184	K181116	000