HEARTONE EVENT RECORDER AND TRANSMITTER


Device Classification Name

transmitters and receivers, electrocardiograph, telephone

510(k) Number K023418
Device Name HEARTONE EVENT RECORDER AND TRANSMITTER
Original Applicant
AEROTEL MEDICAL SYSTEMS (1998) LTD.
377 route 17
hasbrouck heights, 
NJ 
07604

Original Contact george myers
Regulation Number 870.2920
Classification Product Code
DXH  
Date Received 10/11/2002
Decision Date 11/06/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No