MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY


definition

Device Classification Name

standard polysomnograph with electroencephalograph

510(k) Number K001013
Device Name MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY
Original Applicant
AIRSEP CORP.
290 creekside dr.
buffalo, 
NY 
14228

Original Contact peter weisenborn
Regulation Number 882.1400
Classification Product Code
OLV  
Subsequent Product Code
DQA  
Date Received 03/29/2000
Decision Date 05/16/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

Type Traditional
Reviewed by Third Party No

Combination Product

No