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510(k) K982090

PACEART HOME TRAK PLUS EASI EVENT RECORDER SYSTEM by Paceart, Inc. — Product Code DXH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1999
Date Received
June 15, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transmitters And Receivers, Electrocardiograph, Telephone
Device Class
Class II
Regulation Number
870.2920
Review Panel
CV
Submission Type

Other clearances by Paceart, Inc.

  • K012407 — PACEART TX3 CARDIAC EVENT RECORDER (August 14, 2001)
  • 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)
  • K915632 — PACEART CPTS-86/12 (April 14, 1992)
  • K880283 — PACEART PACEMAKER PATIENT TEST SYST/TEL OPT CPTS (March 9, 1988)
  • K870909 — PACEMAKER FUNCTION ANALYZER (April 27, 1987)

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