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510(k) K913013

TCPO2 9260 MODULE - SYSTEM ATHENA by S & W Medico Teknik — Product Code LKD

K913013 is an FDA 510(k) premarket notification submitted by S & W Medico Teknik for the device "TCPO2 9260 MODULE - SYSTEM ATHENA". The FDA issued a decision of Substantially Equivalent on May 3, 1994. The device falls under product code LKD (Monitor, Carbon-Dioxide, Cutaneous), a Class II device regulated under 21 CFR 868.2480. S & W Medico Teknik has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 1994
Date Received
July 8, 1991
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 S & W Medico Teknik

  • K964593 — DIASCOPE TRAVELLER PLUS (4053) (June 30, 1997)
  • K940933 — 9267 SPO2 ATHENA MODULE (November 29, 1995)
  • K942196 — 3050 DIASCOPE NT PATIENT MONITOR (June 28, 1995)
  • K934887 — 9750 ATHENA ETHERNET OPTION (January 14, 1994)
  • K915633 — MOD. TYPE 9230 TEMP 1 AND TEMP 2 SYSTEM ATHENA (June 29, 1993)
  • K930134 — 9055 IRCA OPTION FOR SYSTEM ATHENA 9050 NT (April 9, 1993)
  • K923418 — 9293/1 INTERFACE MODULE (February 23, 1993)
  • K911611 — SYSTEM ATHENA, MODIFICATION (February 5, 1993)
  • K922314 — VENTILATOR INTERFACE 9291/4 (December 17, 1992)
  • K912815 — NIBP 9225 COMBI (October 9, 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