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510(k) K915632

PACEART CPTS-86/12 by Paceart, Inc. — Product Code KRE

K915632 is an FDA 510(k) premarket notification submitted by Paceart, Inc. for the device "PACEART CPTS-86/12". The FDA issued a decision of Substantially Equivalent on April 14, 1992. The device falls under product code KRE (Analyzer, Pacemaker Generator Function, Indirect), a Class II device regulated under 21 CFR 870.3640. Paceart, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 1992
Date Received
December 17, 1991
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 Paceart, Inc.

  • K012407 — PACEART TX3 CARDIAC EVENT RECORDER (August 14, 2001)
  • K982090 — PACEART HOME TRAK PLUS EASI EVENT RECORDER SYSTEM (January 26, 1999)
  • K973141 — HEART ACCESS PLUS CARDIAC EVENT RECORDER (November 12, 1997)
  • K960721 — PACEART WRIST ELECTRODES (July 18, 1996)
  • K952065 — PACEART CARDIOVOICE (January 16, 1996)
  • K931296 — PACEART CARDIOPHONE (October 1, 1993)
  • K880283 — PACEART PACEMAKER PATIENT TEST SYST/TEL OPT CPTS (March 9, 1988)
  • K870909 — PACEMAKER FUNCTION ANALYZER (April 27, 1987)

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)
  • K922742 — HPM 40 HEART PACEMAKER MONITOR (March 18, 1993)
  • 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