SONOTRAX ULTRASONIC FETAL AND VASCULAR POCKET DOPPLER, MODELS LITE, BASIC, PRO, II, II PRO AND VASCULAR


Device Classification Name

monitor, ultrasonic, fetal

510(k) Number K080087
Device Name SONOTRAX ULTRASONIC FETAL AND VASCULAR POCKET DOPPLER, MODELS LITE, BASIC, PRO, II, II PRO AND VASCULAR
Applicant
EDAN INSTRUMENTS, INC.
1 odell plaza
yonkers, 
NY 
10701

Applicant Contact william stern
Correspondent
EDAN INSTRUMENTS, INC.
1 odell plaza
yonkers, 
NY 
10701

Correspodent Contact william stern
Regulation Number 884.2660
Classification Product Code
KNG  
Subsequent Product Code
HEP  
Date Received 01/11/2008
Decision Date 03/11/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No