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510(k) K070136

AUDICOR 200 SYSTEM, MODELS 200D AND 200S by Inovise Medical, Inc. — Product Code DPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 2007
Date Received
January 16, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocardiograph
Device Class
Class II
Regulation Number
870.2340
Review Panel
CV
Submission Type

Other clearances by Inovise Medical, Inc.

  • K151433 — AUDICOR CA300/CC100 Analyzer with SDB (March 18, 2016)
  • K131883 — AUDICOR CPAM WITH SDB (ACCELEROMETER BASED) (April 11, 2014)
  • K130660 — AUDICOR CPAM WITH SDB (SINGLE SENSOR) (October 11, 2013)
  • K120462 — AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED (September 20, 2012)
  • K110569 — AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR) (October 24, 2011)
  • K103516 — AUDICOR SENSOR-ADAPTER MODEL AUDICOR SENSOR-ADAPTER 4.0 (February 4, 2011)
  • K080602 — AUDICOR SENSOR, MODELS: 2.0, 3.0 (September 25, 2008)
  • K073545 — AUDICOR, HEMO AMBULATORY MONITOR (September 9, 2008)
  • K051450 — EXTENDED MEASUREMENTS SYSTEM (November 10, 2005)
  • K043074 — LIBERTY SYSTEM (February 22, 2005)

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