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510(k) K151329

SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet by Sentec AG — Product Code LKD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2015
Date Received
May 18, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Carbon-Dioxide, Cutaneous
Device Class
Class II
Regulation Number
868.2480
Review Panel
AN
Submission Type

Other clearances by Sentec AG

  • K243765 — LuMon(TM) System (August 7, 2025)
  • K232516 — Sentec Digital Monitoring System (SDMS) tCOM+ (May 17, 2024)
  • K101690 — SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR AD (December 3, 2010)
  • K071672 — SENTEC DIGITAL MONITORING SYSTEM (September 12, 2007)
  • K041548 — SENTEC DIGITAL MONITOR MODEL #SDM (August 9, 2004)
  • K862340 — SENTEC LASER GUIDE LINE, MODEL SGL-05 (July 11, 1986)

Other clearances for product code LKD

  • K232516 — Sentec Digital Monitoring System (SDMS) tCOM+ (May 17, 2024)
  • K131253 — PERIFLUX 6000 (October 22, 2013)
  • K110474 — PHILIPS INTELLIVUE TCG10 (September 30, 2011)
  • K101690 — SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR AD (December 3, 2010)
  • K093154 — TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM (February 5, 2010)
  • K043357 — TOSCA 500 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, MODEL 5202009 (March 4, 2005)
  • K043003 — TCM40 MONITORING SYSTEM (March 1, 2005)
  • K041548 — SENTEC DIGITAL MONITOR MODEL #SDM (August 9, 2004)
  • K990960 — PERIMED TRANSCUTANEOUS PO2 AND PCO2 MONITOR (PF5040) (September 23, 1999)
  • K980756 — COROMETRICS TRANSCUTANEOUS TCPO2/CO2 MODULE (November 5, 1998)