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510(k) K151433

AUDICOR CA300/CC100 Analyzer with SDB by Inovise Medical, Inc. — Product Code MNR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 2016
Date Received
May 28, 2015
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 Inovise Medical, Inc.

  • 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)
  • K070136 — AUDICOR 200 SYSTEM, MODELS 200D AND 200S (April 13, 2007)
  • K051450 — EXTENDED MEASUREMENTS SYSTEM (November 10, 2005)
  • K043074 — LIBERTY SYSTEM (February 22, 2005)

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