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510(k) K130660

AUDICOR CPAM WITH SDB (SINGLE SENSOR) by Inovise Medical, Inc. — Product Code MLO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 2013
Date Received
March 12, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocardiograph, Ambulatory, With Analysis Algorithm
Device Class
Class II
Regulation Number
870.2800
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)
  • 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)
  • K070136 — AUDICOR 200 SYSTEM, MODELS 200D AND 200S (April 13, 2007)
  • K051450 — EXTENDED MEASUREMENTS SYSTEM (November 10, 2005)
  • K043074 — LIBERTY SYSTEM (February 22, 2005)

Other clearances for product code MLO

  • K241890 — Philips Holter Analysis System (March 21, 2025)
  • K240794 — Frontier X Plus (November 8, 2024)
  • K200833 — RX-1 Rhythm Express Remote Cardiac Monitoring System (September 2, 2020)
  • K193177 — CER-S (August 26, 2020)
  • K182030 — Faros Mobile (November 8, 2018)
  • K140847 — CARDIOSPY ECG HOLTER SYSTEMS (December 5, 2014)
  • K131897 — CV3000 HOLTER ANALYSIS SYSTEM (November 26, 2013)
  • K120462 — AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED (September 20, 2012)
  • K111487 — NH-301 AMBULATORY ECG ANALYSIS SOFTWARE (November 10, 2011)
  • K110569 — AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR) (October 24, 2011)