DA VINCHI EEG AND EMG/EP SYSTEMS

Stimulator, Electrical, Evoked Response

AIRSEP CORP.

The following data is part of a premarket notification filed by Airsep Corp. with the FDA for Da Vinchi Eeg And Emg/ep Systems.

Pre-market Notification Details

Device IDK000963
510k NumberK000963
Device Name:DA VINCHI EEG AND EMG/EP SYSTEMS
ClassificationStimulator, Electrical, Evoked Response
Applicant AIRSEP CORP. 290 CREEKSIDE DR. Buffalo,  NY  14228
ContactPeter Weisenborn
CorrespondentPeter Weisenborn
AIRSEP CORP. 290 CREEKSIDE DR. Buffalo,  NY  14228
Product CodeGWF  
Subsequent Product CodeGWE
Subsequent Product CodeGWJ
Subsequent Product CodeGWQ
Subsequent Product CodeIKN
Subsequent Product CodeJXE
Subsequent Product CodeOLT
CFR Regulation Number882.1870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-03-24
Decision Date2000-10-20

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