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510(k) K896437

KONTRON SIGMA 44 HVCD ULTRASOUND IMAGING SYSTEM by Kontron Instruments, Inc. — Product Code DPT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 1990
Date Received
November 9, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Probe, Blood-Flow, Extravascular
Device Class
Class II
Regulation Number
870.2120
Review Panel
CV
Submission Type

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  • K925248 — MODIFICATION OF INTRA-AORTIC BALLOON CATHETERS (September 27, 1993)
  • K923603 — INTRA-AORTIC BALLOON PUMP CATHETER - MODIFICATION (March 8, 1993)
  • K905313 — KONTRON INTRA-AORTIC BALLOON PUMP, MODEL KAAT II (June 19, 1991)
  • K903344 — 9.5 FR PERCUTANEOUS DB LUMEN 40CC FLEXI-CATH (TM) (January 15, 1991)
  • K892222 — 9.5F PERCU DOUBLE LUMEN INTRA-AORTIC BALLOON (September 14, 1990)
  • K882955 — SUPERMON NEONATAL NON-INVASIVE BLOOD PRESS. 7283 (January 26, 1990)
  • K896386 — MINIMON 7133B PATIENT MONITOR (December 13, 1989)
  • K896417 — KONTRON KOLORMON 7250 PATIENT MONITOR (December 12, 1989)

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