BRAINLAB HEADPINS

Neurological Stereotaxic Instrument

BRAINLAB, AG

The following data is part of a premarket notification filed by Brainlab, Ag with the FDA for Brainlab Headpins.

Pre-market Notification Details

Device IDK954789
510k NumberK954789
Device Name:BRAINLAB HEADPINS
ClassificationNeurological Stereotaxic Instrument
Applicant BRAINLAB, AG 600 GLEN COURT Moorestown,  NJ  08057
ContactStefan Lip[pstreu
CorrespondentStefan Lip[pstreu
BRAINLAB, AG 600 GLEN COURT Moorestown,  NJ  08057
Product CodeHAW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-10-18
Decision Date1996-08-12

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04056481004033 K954789 000
04056481003937 K954789 000
04056481003944 K954789 000
04056481003951 K954789 000
04056481003968 K954789 000
04056481003975 K954789 000
04056481003982 K954789 000
04056481003999 K954789 000
04056481004002 K954789 000
04056481004019 K954789 000
04056481004026 K954789 000
04056481003920 K954789 000

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