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510(k) K891481

SIEMENS SIRECUST TRANSCUTANEOUS CARBON DIOXIDE by Siemens Medical Electronics — Product Code LKD

K891481 is an FDA 510(k) premarket notification submitted by Siemens Medical Electronics for the device "SIEMENS SIRECUST TRANSCUTANEOUS CARBON DIOXIDE". The FDA issued a decision of Substantially Equivalent on September 29, 1989. The device falls under product code LKD (Monitor, Carbon-Dioxide, Cutaneous), a Class II device regulated under 21 CFR 868.2480. Siemens Medical Electronics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1989
Date Received
March 17, 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 Siemens Medical Electronics

  • K935043 — SIEMENS CLINICAL WORK STATION (April 7, 1995)
  • K921930 — SIEMENS SIRECUST 700 BEDSIDES/ACCESSORIES, MODIFI (May 7, 1993)
  • K920445 — SIEMENS SIRECUST PENTA SYSTEM AND ACCESSORIES (March 2, 1993)
  • K914765 — SIEMENS NP NONINVASIVE BLOOD PRESS MEASUREMENT SYS (November 6, 1992)
  • K912070 — SIEMENS RADIOTOM 904 & 904E ELECTROSURGERY UNIT (April 23, 1992)
  • K913489 — SIEMENS MICRO2 PULSE OXIMETER (October 30, 1991)
  • K905775 — SIEMENS ETCO2 CARTRIDGE (March 11, 1991)
  • K900319 — SIEMENS SIRECUST 1481T, DIGITAL TELEMETRY SYSTEM (June 28, 1990)
  • K901771 — SIEMENS SIRECUST 732, PATIENT MONITOR (May 30, 1990)
  • K894460 — SIEMENS SIRECUST 730, PATIENT MONITOR W/ARRHYTHMIA (October 2, 1989)

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