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510(k) K973141

HEART ACCESS PLUS CARDIAC EVENT RECORDER by Paceart, Inc. — Product Code DXH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 1997
Date Received
August 21, 1997
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)
  • K982090 — PACEART HOME TRAK PLUS EASI EVENT RECORDER SYSTEM (January 26, 1999)
  • 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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