THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3812B TELESTATION (M310A/12B)


Device Classification Name

transmitters and receivers, physiological signal, radiofrequency

510(k) Number K023749
Device Name THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3812B TELESTATION (M310A/12B)
Original Applicant
PHILIPS MEDICAL SYSTEMS
3000 minuteman rd.
andover, 
MA 
01810 -1099

Original Contact j.p. ouellette
Regulation Number 870.2910
Classification Product Code
DRG  
Date Received 11/08/2002
Decision Date 11/19/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No