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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Holder, Head, Neurosurgical (Skull Clamp)
510(k) Number K191979
Device Name DORO QR3 XTom Headholder System
Applicant
Pro Med Instruments GmbH
Boetzinger Str. 38
Freiburg,  DE 79111
Applicant Contact Sandra Untenberger
Correspondent
Pro Med Instruments GmbH
Boetzinger Str. 38
Freiburg,  DE 79111
Correspondent Contact Sandra Untenberger
Regulation Number882.4460
Classification Product Code
HBL  
Date Received07/24/2019
Decision Date 10/22/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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