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510(k) K890299

KONTRON PULSE OXIMETER 7840 by Kontron Instruments, Inc. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 1989
Date Received
January 19, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter
Device Class
Class II
Regulation Number
870.2700
Review Panel
AN
Submission Type

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  • 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)
  • K896437 — KONTRON SIGMA 44 HVCD ULTRASOUND IMAGING SYSTEM (December 3, 1990)
  • 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)

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