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510(k) K010945

HEARTCARD, MODEL 5258 by Instromedix — Product Code DXH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2001
Date Received
March 29, 2001
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 Instromedix

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  • K964036 — CARDIOMAGIC 2000 SOFTWARE (July 18, 1997)
  • K955060 — ACCELERATED TRANSMISSION PROTOCOL (April 8, 1996)
  • K951096 — LIFESIGNS RECEIVING CENER 2000 TRANSTELEPHONIC RECEIVER (January 16, 1996)
  • K945476 — HEARTHWATCH III(TM) (November 9, 1995)
  • K950003 — CARDIOMAGIC(R) SOFTWARE ENHANCEMENTS (October 31, 1995)
  • K944362 — HEARTCARD CARDIAC EVENT MONITOR (September 7, 1995)
  • K943931 — CARRYALL ENHANCEMENTS (April 4, 1995)
  • K935586 — PRINCE (November 8, 1994)
  • K925639 — CARDIOMAGIC SOFTWARE (June 22, 1993)

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