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510(k) K942490

BABE COMPUTER POGRAM FOR OBSTETRIC ULTRASOUND by Medical Soft, Inc. — Product Code HEM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 1995
Date Received
May 25, 1994
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

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  • K900271 — MODEL OB-500 FETAL GROWTH ANALYSIS & OPTION OBLINK (April 19, 1990)
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  • K885061 — SIEMENS INTRAVAGINAL TRANSDUCER (February 23, 1989)
  • K881185 — ANNULAR ARRAY PROBES FOR ARTIS 3200 DIAG. ULTRA. (June 1, 1988)
  • K880900 — SSD-620 LINEAR/CONVEX ARRAY SECTOR SCANNER (June 1, 1988)