Schoelly Cystoscopes/Hysteroscopes And Accessories

Hysteroscope (and Accessories)

Schoelly Fiberoptic GmbH

The following data is part of a premarket notification filed by Schoelly Fiberoptic Gmbh with the FDA for Schoelly Cystoscopes/hysteroscopes And Accessories.

Pre-market Notification Details

Device IDK201970
510k NumberK201970
Device Name:Schoelly Cystoscopes/Hysteroscopes And Accessories
ClassificationHysteroscope (and Accessories)
Applicant Schoelly Fiberoptic GmbH Robert-Bosch-Str. 1-3 Denzlingen,  DE D-79211
ContactSandra Baumann
CorrespondentPamela Papineau
Delphi Medical Device Consulting, Inc. 5 Whitcomb Avenue Ayer,  MA  01432
Product CodeHIH  
CFR Regulation Number884.1690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-15
Decision Date2020-10-08

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