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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Imager, Ultrasonic Obstetric-Gynecologic
510(k) Number K860233
Device Name 5 MHZ INTRACAVITARY PROBE, MODEL H4222V
Applicant
General Electric Co.
P.O. Box 414
Milwaukee,  WI  53201
Applicant Contact HOWARD II
Correspondent
General Electric Co.
P.O. Box 414
Milwaukee,  WI  53201
Correspondent Contact HOWARD II
Regulation Number884.2225
Classification Product Code
HEM  
Date Received01/22/1986
Decision Date 06/02/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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