OLYMPUS BF TYPE UM40


Device Classification Name

transducer, ultrasonic, diagnostic

510(k) Number K021204
Device Name OLYMPUS BF TYPE UM40
Original Applicant
OLYMPUS OPTICAL CO., LTD.
two corporate center dr.
melville, 
NY 
11747 -3157

Original Contact laura storms-tyler
Regulation Number 892.1570
Classification Product Code
ITX  
Subsequent Product Code
KOG  
Date Received 04/16/2002
Decision Date 05/01/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No