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510(k) K900271

MODEL OB-500 FETAL GROWTH ANALYSIS & OPTION OBLINK by Digisonics, Inc. — Product Code HEM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 1990
Date Received
January 19, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Imager, Ultrasonic Obstetric-Gynecologic
Device Class
Class II
Regulation Number
884.2225
Review Panel
OB
Submission Type

Other clearances by Digisonics, Inc.

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  • K885061 — SIEMENS INTRAVAGINAL TRANSDUCER (February 23, 1989)
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  • K880900 — SSD-620 LINEAR/CONVEX ARRAY SECTOR SCANNER (June 1, 1988)