ARTISAN ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY

Standard Polysomnograph With Electroencephalograph

AIRSEP CORP.

The following data is part of a premarket notification filed by Airsep Corp. with the FDA for Artisan Acquisition System For Eeg And Polysomnography.

Pre-market Notification Details

Device IDK992283
510k NumberK992283
Device Name:ARTISAN ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY
ClassificationStandard Polysomnograph With Electroencephalograph
Applicant AIRSEP CORP. 290 CREEKSIDE DR. Buffalo,  NY  14228
ContactGreg Dziomba
CorrespondentGreg Dziomba
AIRSEP CORP. 290 CREEKSIDE DR. Buffalo,  NY  14228
Product CodeOLV  
CFR Regulation Number882.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-07-07
Decision Date1999-08-27

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