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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 K880900
Device Name SSD-620 LINEAR/CONVEX ARRAY SECTOR SCANNER
Applicant
Corometrics Medical Systems, Inc.
61 Barnes Park Rd. N.
P.O. Box 333
Wallingford,  CT  06492
Applicant Contact JOSEPH P LENZEN
Correspondent
Corometrics Medical Systems, Inc.
61 Barnes Park Rd. N.
P.O. Box 333
Wallingford,  CT  06492
Correspondent Contact JOSEPH P LENZEN
Regulation Number884.2225
Classification Product Code
HEM  
Date Received03/02/1988
Decision Date 06/01/1988
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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