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510(k) K030316

AUDICOR COR SENSOR (AND ACCESSORY ADAPTOR) by Inovise Medical, Inc. — Product Code DRX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 2003
Date Received
January 30, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Electrode, Electrocardiograph
Device Class
Class II
Regulation Number
870.2360
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)
  • K070136 — AUDICOR 200 SYSTEM, MODELS 200D AND 200S (April 13, 2007)
  • K051450 — EXTENDED MEASUREMENTS SYSTEM (November 10, 2005)

Other clearances for product code DRX

  • K171244 — Physiotrace (August 23, 2017)
  • K140096 — HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE (July 24, 2014)
  • K123658 — BIOMODULE 3-M1 (April 24, 2013)
  • K101576 — CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODES (July 22, 2010)
  • K101685 — IP-SET (July 1, 2010)
  • K100129 — AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X (June 11, 2010)
  • K093327 — INTCO TAB ELECTRODE (May 10, 2010)
  • K100315 — 12 LEAD GLOVE (April 23, 2010)
  • K092744 — NEONATAL ECG ELECTRODE, M203KEN (December 10, 2009)
  • K092389 — DISPOSAL ECG ELECTRODES, MODEL EASYRODE (October 13, 2009)