CLEARSCAN


Device Classification Name

transducer, ultrasonic, diagnostic

510(k) Number K080119
Device Name CLEARSCAN
Applicant
ESI, INC.
377 route 17 s
hasbrouck heights, 
NJ 
07604

Applicant Contact george myers
Correspondent
ESI, INC.
377 route 17 s
hasbrouck heights, 
NJ 
07604

Correspodent Contact george myers
Regulation Number 892.1570
Classification Product Code
ITX  
Date Received 01/17/2008
Decision Date 02/21/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No