TM2000 FETALTRACE TRANSTELEPHONIC RECEIVING CENTER


Device Classification Name

system, monitoring, perinatal

510(k) Number K021574
Device Name TM2000 FETALTRACE TRANSTELEPHONIC RECEIVING CENTER
Original Applicant
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
2 pekeris st.
po box 527
rehovot, 

IL

76100

Original Contact alex gonorovsky
Regulation Number 884.2740
Classification Product Code
HGM  
Date Received 05/14/2002
Decision Date 08/12/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No