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510(k) K890517

TRANSCUTANEOUS O2/CO2 MONITOR by Novametrix Medical Systems, Inc. — Product Code LKD

K890517 is an FDA 510(k) premarket notification submitted by Novametrix Medical Systems, Inc. for the device "TRANSCUTANEOUS O2/CO2 MONITOR". The FDA issued a decision of Substantially Equivalent on April 14, 1989. The device falls under product code LKD (Monitor, Carbon-Dioxide, Cutaneous), a Class II device regulated under 21 CFR 868.2480. Novametrix Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 1989
Date Received
January 30, 1989
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 Novametrix Medical Systems, Inc.

  • K010451 — NOVAMETRIX MARQUETTE COMPATIBLE SENSORS (April 25, 2001)
  • K000794 — MODIFICATION TO MARSPO2, MODEL 2001 (April 10, 2000)
  • K993979 — MARSPO2, MODEL 2001 (February 22, 2000)
  • K982499 — COSMO PLUS WITH NICO, MODEL 8200 (October 16, 1998)
  • K964360 — VENT(VENTCHECK) HANDHELD RESPIRATORY/MECHANICS MONITOR MODEL 101 (April 4, 1997)
  • K963380 — CO 2 SMO PLUS (January 22, 1997)
  • K963327 — TIDAL WAVE CARBON DIOXIDE MONITOR, MODEL 610 (November 20, 1996)
  • K960831 — VENTRAK RMMS 1550 (May 29, 1996)
  • K924626 — NOVAMETRIX MODEL 510 (December 3, 1993)
  • K920379 — NOVAMETRIX MODEL 7100 COMB. END TIDAL CO2 & PUL OX (July 15, 1992)

Other clearances for product code LKD

  • K232516 — Sentec Digital Monitoring System (SDMS) tCOM+ (May 17, 2024)
  • K151329 — SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V- (December 17, 2015)
  • 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)

FDA data resources