Device Classification Name Endoscope, Neurological 510(K) Number K181116 Device Name CONVIVO Applicant
Carl Zeiss Meditec AG Goeschwitzer Str. 51-52 Jena, DE 07745 Applicant Contact Christian Muenster Correspondent
Carl Zeiss Meditec, Inc. 5160 Hacienda Drive Dublin, CA 94568 Correspondent Contact Mandy Ambrecht Regulation Number 882.1480 Classification Product Code
GWG Subsequent Product Code
OWN Date Received 04/27/2018 Decision Date 10/25/2018 Decision Substantially Equivalent (SESE) Regulation Medical Specialty Neurology 510k Review Panel General & Plastic Surgery Type Traditional Reviewed By Third Party No Combination Product Yes There is FDA approval. Decision date Oct 25 2018.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K181116
Ann: Trading Halt Request, page-12
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