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510(k) K890637

EXTENDED OBSTETRICS SOFTWARE COMPUTATION PACKAGE by Elscint, Inc. — Product Code HEM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 1989
Date Received
February 8, 1989
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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Other clearances for product code HEM

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  • K900271 — MODEL OB-500 FETAL GROWTH ANALYSIS & OPTION OBLINK (April 19, 1990)
  • K881329 — FETAL DOPPLER FOR ULTRAMARK 4 AND 8 (April 14, 1989)
  • 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)