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510(k) K081861

HOLTER LX ANALYSIS by North East Monitoring, Inc. — Product Code MNR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 2008
Date Received
July 1, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilatory Effort Recorder
Device Class
Class II
Regulation Number
868.2375
Review Panel
AN
Submission Type

Other clearances by North East Monitoring, Inc.

  • K142424 — DR300 HOLTER MONITOR (November 25, 2014)
  • 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)
  • K960925 — NORTHEAST MONITORING DR180 (July 31, 1996)
  • K930564 — HOLTER FOR WINDOWS (April 19, 1995)

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