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510(k) K885061

SIEMENS INTRAVAGINAL TRANSDUCER by Siemens Medical Solutions USA, Inc. — Product Code HEM

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: February 23, 1989
Date Received: December 6, 1988
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)
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K881329 — FETAL DOPPLER FOR ULTRAMARK 4 AND 8 (April 14, 1989)
K881185 — ANNULAR ARRAY PROBES FOR ARTIS 3200 DIAG. ULTRA. (June 1, 1988)
K880900 — SSD-620 LINEAR/CONVEX ARRAY SECTOR SCANNER (June 1, 1988)