Disposable Pre-calibrated Suction

Neurological Stereotaxic Instrument

Brainlab AG

The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Disposable Pre-calibrated Suction.

Pre-market Notification Details

Device IDK201752
510k NumberK201752
Device Name:Disposable Pre-calibrated Suction
ClassificationNeurological Stereotaxic Instrument
Applicant Brainlab AG Olof-Palme-Str. 9 Munich,  DE 81829
ContactChiara Cunico
CorrespondentChiara Cunico
Brainlab AG Olof-Palme-Str. 9 Munich,  DE 81829
Product CodeHAW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-26
Decision Date2021-01-29

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