SCHOELLY SINUSCOPE

Nasopharyngoscope (flexible Or Rigid)

SCHOELLY FIBEROPTIC GMBH

The following data is part of a premarket notification filed by Schoelly Fiberoptic Gmbh with the FDA for Schoelly Sinuscope.

Pre-market Notification Details

Device IDK142249
510k NumberK142249
Device Name:SCHOELLY SINUSCOPE
ClassificationNasopharyngoscope (flexible Or Rigid)
Applicant SCHOELLY FIBEROPTIC GMBH ROBERT-BOSCH-STR. 1-3 Denzlingen,  DE D-79211
ContactSandra Baumann
CorrespondentPamela Papineau
DELPHI MEDICAL DEVICE CONSULTING, INC. 5 WHITCOMB AVE Ayer,  MA  01432
Product CodeEOB  
CFR Regulation Number874.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-08-14
Decision Date2015-01-27
Summary:summary

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