MODIFICATION TO HYPERQ SYSTEM


Device Classification Name

monitor,physiological,patient(without arrhythmia detection or alarms)

510(k) Number K072389
Device Name MODIFICATION TO HYPERQ SYSTEM
Applicant
BIOLOGICAL SIGNAL PROCESSING, LTD.
291 hillside avenue
somerset, 
MA 
02726

Applicant Contact george j hattub
Correspondent
BIOLOGICAL SIGNAL PROCESSING, LTD.
291 hillside avenue
somerset, 
MA 
02726

Correspodent Contact george j hattub
Regulation Number 870.2300
Classification Product Code
MWI  
Date Received 08/24/2007
Decision Date 09/18/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No