DORO RADIOLUCENT HEADREST SYSTEM ( ALSO MRI-COMPATIBLE) AND COMPONENTS

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 Radiolucent Headrest System ( Also Mri-compatible) And Components.

Pre-market Notification Details

Device IDK063494
510k NumberK063494
Device Name:DORO RADIOLUCENT HEADREST SYSTEM ( ALSO MRI-COMPATIBLE) AND COMPONENTS
ClassificationHolder, Head, Neurosurgical (skull Clamp)
Applicant PRO-MED INSTRUMENTS GMBH 5450 LEE ST, STE 1 Lehigh Acres,  FL  33971
ContactEdgar Schuele
CorrespondentEdgar Schuele
PRO-MED INSTRUMENTS GMBH 5450 LEE ST, STE 1 Lehigh Acres,  FL  33971
Product CodeHBL  
CFR Regulation Number882.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-11-20
Decision Date2007-05-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04250435534120 K063494 000
04250435516256 K063494 000
04250435516249 K063494 000
04250435516232 K063494 000
04250435502419 K063494 000
04250435502402 K063494 000
04250435502396 K063494 000
04250435502389 K063494 000
04250435502310 K063494 000
04250435502181 K063494 000
04250435502044 K063494 000
04250435502037 K063494 000
04250435502020 K063494 000
04250435516270 K063494 000
04250435516287 K063494 000
04250435520383 K063494 000
04250435534106 K063494 000
04250435533987 K063494 000
04250435533970 K063494 000
04250435533949 K063494 000
04250435533932 K063494 000
04250435532140 K063494 000
04250435532133 K063494 000
04250435532072 K063494 000
04250435520918 K063494 000
04250435520901 K063494 000
04250435520420 K063494 000
04250435520390 K063494 000
04250435535769 K063494 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.