GRASS-TELEFACTOR AS40 AMPLIFIER SYSTEM


Device Classification Name

standard polysomnograph with electroencephalograph

510(k) Number K021807
Device Name GRASS-TELEFACTOR AS40 AMPLIFIER SYSTEM
Original Applicant
GRASS INSTRUMENT CO.
570 liberty st.
braintree, 
MA 
02185

Original Contact peter l fuller
Regulation Number 882.1400
Classification Product Code
OLV  
Subsequent Product Code
GWQ  
Date Received 06/03/2002
Decision Date 08/29/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No