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510(k) K943931

CARRYALL ENHANCEMENTS by Instromedix, Inc. — Product Code DXH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 1995
Date Received
August 12, 1994
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, Inc.

  • K010945 — HEARTCARD, MODEL 5258 (June 12, 2001)
  • K964408 — POSEIDON CARDIAC MONITORING SYSTEM (PCMS) (July 23, 1997)
  • 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)
  • K935586 — PRINCE (November 8, 1994)
  • K925639 — CARDIOMAGIC SOFTWARE (June 22, 1993)

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  • K233521 — QT ECG (QTERD100) (December 6, 2023)
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  • K220795 — QT ECG (September 26, 2022)
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