CARDIODIRECT, MODELS 12M, 12I, 12S


Device Classification Name

electrocardiograph

510(k) Number K024283
Device Name CARDIODIRECT, MODELS 12M, 12I, 12S
Original Applicant
REYNOLDS MEDICAL LTD.
377 rt. 17 s.
hasbrouck heights, 
NJ 
07604

Original Contact george myers
Regulation Number 870.2340
Classification Product Code
DPS  
Date Received 12/23/2002
Decision Date 08/01/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No