DORO QR3 Headrest System (Aluminum)

Holder, Head, Neurosurgical (skull Clamp)

Pro Med Instruments GmbH

The following data is part of a premarket notification filed by Pro Med Instruments Gmbh with the FDA for Doro Qr3 Headrest System (aluminum).

Pre-market Notification Details

Device IDK203505
510k NumberK203505
Device Name:DORO QR3 Headrest System (Aluminum)
ClassificationHolder, Head, Neurosurgical (skull Clamp)
Applicant pro Med Instruments GmbH Boetziger Str. 38 Freiburg,  DE 79111
ContactMuhammad Zubair
CorrespondentMuhammad Zubair
pro Med Instruments GmbH Boetziger Str. 38 Freiburg,  DE 79111
Product CodeHBL  
CFR Regulation Number882.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-30
Decision Date2021-03-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04250435514917 K203505 000
04250435506196 K203505 000
04250435500569 K203505 000
04250435500019 K203505 000

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