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510(k) K960925

NORTHEAST MONITORING DR180 by North East Monitoring, Inc. — Product Code DSH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 1996
Date Received
March 6, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Recorder, Magnetic Tape, Medical
Device Class
Class II
Regulation Number
870.2800
Review Panel
CV
Submission Type

Other clearances by North East Monitoring, Inc.

  • K142424 — DR300 HOLTER MONITOR (November 25, 2014)
  • K081861 — HOLTER LX ANALYSIS (December 4, 2008)
  • K070014 — AUTO DETECT FOR TELAHEART DR200/E-A (May 25, 2007)
  • K061293 — TELAHEART DIGITAL RECORDER (August 25, 2006)
  • K041901 — SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDER (August 31, 2004)
  • K004007 — DR180+OXY (January 25, 2001)
  • K001288 — DR180-II (July 20, 2000)
  • K983576 — DR180-R/OXY (March 23, 1999)
  • K930564 — HOLTER FOR WINDOWS (April 19, 1995)

Other clearances for product code DSH

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  • K243650 — Zio® monitor (DFG0001) (August 15, 2025)
  • K243603 — AeviceMD (May 5, 2025)
  • K242583 — AT-Patch (ATP-C130/ATP-C70) (May 2, 2025)
  • K232670 — HiCardi+ H100 (September 20, 2024)
  • K233906 — S-Patch (S-Patch ExL) (February 16, 2024)
  • K231104 — ABPMpro (November 27, 2023)
  • K233110 — Carnation Ambulatory Monitor (November 22, 2023)
  • K230184 — Holter ECG and ABP System (September 25, 2023)
  • K231289 — S-Patch Ex Wearable ECG Patch (August 30, 2023)