OLYMPUS UM 2R/3R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR FEMALE REPRODUCTIVE TRACT


definition

Device Classification Name

transducer, ultrasonic, diagnostic

510(k) Number K001203
Device Name OLYMPUS UM 2R/3R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR FEMALE REPRODUCTIVE TRACT
Original Applicant
THE OLYMPUS OPTICAL CO.
two corporate dr.
melville, 
NY 
11747

Original Contact laura storms-tyler
Regulation Number 892.1570
Classification Product Code
ITX  
Date Received 04/13/2000
Decision Date 05/26/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

Type Traditional
Reviewed by Third Party No

Combination Product

No