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510(k) K832959

PACEMAKER SYS. ANALYZER 378 by Siemens Elema AB — Product Code KRE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 1983
Date Received
August 30, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Pacemaker Generator Function, Indirect
Device Class
Class II
Regulation Number
870.3640
Review Panel
CV
Submission Type

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  • K872278 — SIEMENS O2-AIR MIXER 965 (September 3, 1987)
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Other clearances for product code KRE

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  • K032926 — EKG SPEAKS (October 15, 2003)
  • K922742 — HPM 40 HEART PACEMAKER MONITOR (March 18, 1993)
  • K915632 — PACEART CPTS-86/12 (April 14, 1992)
  • K895535 — PACEVIEW (March 19, 1990)
  • K870909 — PACEMAKER FUNCTION ANALYZER (April 27, 1987)
  • K833647 — PACEMAKER SYS ANALYZER #384 (December 16, 1983)
  • K803286 — CARDIOMEMO (March 17, 1981)
  • K800696 — ELECTRONIC PACEMAKER WAVEFORM ANALYZER (August 14, 1980)