ARTISAN ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY


Device Classification Name

standard polysomnograph with electroencephalograph

510(k) Number K992283
Device Name ARTISAN ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY
Applicant
AIRSEP CORP.
290 creekside dr.
buffalo, 
NY 
14228

Applicant Contact greg dziomba
Correspondent
AIRSEP CORP.
290 creekside dr.
buffalo, 
NY 
14228

Correspodent Contact greg dziomba
Regulation Number 882.1400
Classification Product Code
OLV  
Subsequent Product Code
GWQ  
Date Received 07/07/1999
Decision Date 08/27/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No