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510(k) K922742

HPM 40 HEART PACEMAKER MONITOR by Biotronik, GmbH & Co. — Product Code KRE

K922742 is an FDA 510(k) premarket notification submitted by Biotronik, GmbH & Co. for the device "HPM 40 HEART PACEMAKER MONITOR". The FDA issued a decision of Substantially Equivalent on March 18, 1993. The device falls under product code KRE (Analyzer, Pacemaker Generator Function, Indirect), a Class II device regulated under 21 CFR 870.3640. Biotronik, GmbH & Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 1993
Date Received
June 8, 1992
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

Other clearances by Biotronik, GmbH & Co.

  • K000763 — PX 53/15-BP, MODEL 130 050 AND PX 60/15-BP, MODEL 130 051 (April 6, 2000)
  • K923406 — BIOSCOPE (September 22, 1993)
  • K923026 — PIKOS 01-A AND PIKOS E01-A IMPLANTABLE PACEMAKER (August 19, 1993)
  • K914109 — PIKOS 01 & PIKOS E 01 (February 26, 1992)
  • K910609 — PERMANENT IMPLANTABLE JP ENDOCARDIAL LEADS W/TIP (August 28, 1991)
  • K911142 — LEAD TERMINAL PIN CAPS, VARIOUS MODELS (August 9, 1991)
  • K910608 — PERMANENT IMPLANTABLE FH ENDOCARDIAL LEADS W/TIP (July 30, 1991)
  • K905087 — TRIOS 02 (May 7, 1991)
  • K903929 — LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 60-UP (October 16, 1990)
  • K903928 — LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD DJP 53-UP (October 16, 1990)

Other clearances for product code KRE

  • K110693 — PACEART OPTIMA SYSTEM SOFTWARE (June 8, 2011)
  • K072950 — CYGNUS 12 LEAD ECG MODULE (August 22, 2008)
  • K032926 — EKG SPEAKS (October 15, 2003)
  • 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)
  • K832959 — PACEMAKER SYS. ANALYZER 378 (November 14, 1983)
  • K803286 — CARDIOMEMO (March 17, 1981)
  • K800696 — ELECTRONIC PACEMAKER WAVEFORM ANALYZER (August 14, 1980)

FDA data resources