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510(k) K003943

MICROGAS 7650 TRANSCUTANEOUS MONITOR by Linde Medical Sensors AG — Product Code KLK

K003943 is an FDA 510(k) premarket notification submitted by Linde Medical Sensors AG for the device "MICROGAS 7650 TRANSCUTANEOUS MONITOR". The FDA issued a decision of Substantially Equivalent on May 4, 2001. The device falls under product code KLK (Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia), a Class II device regulated under 21 CFR 868.2500. Linde Medical Sensors AG has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2001
Date Received
December 21, 2000
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
Device Class
Class II
Regulation Number
868.2500
Review Panel
AN
Submission Type

Other clearances by Linde Medical Sensors AG

  • K043357 — TOSCA 500 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, MODEL 5202009 (March 4, 2005)
  • K032291 — TOSCA PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM (August 24, 2004)
  • K991644 — MICROGAS 7650 TRANSCUTANEOUS MONITOR (May 21, 1999)

Other clearances for product code KLK

  • K991644 — MICROGAS 7650 TRANSCUTANEOUS MONITOR (May 21, 1999)
  • K980287 — SIEMENS SC9000/SC9015 TCP02/C02 MODULE (August 12, 1998)
  • K924709 — SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE (January 17, 1996)
  • K924679 — OXYCARE(TM) OXYGEN CONTROLLER/MONITOR (February 21, 1995)
  • K925910 — HEWLETT-PACKARD MODEL M1018A TCPO2/TOPCO2 MODULE (July 29, 1993)
  • K893133 — HORIZON 2110/HORIZON 2210 264-XXX-XXX/261-XXX-XXX (July 14, 1989)
  • K870805 — MODEL 840 TRANSCUTAN. OXYGEN/CARBON DIOX. MONITOR (May 27, 1987)
  • K861861 — 515A NEO-TRAK NEONATAL MONITOR (July 10, 1986)
  • K860124 — HORIZON 2000 TRANSCUTANEOUS GAS MONITORING (May 9, 1986)
  • K860951 — KONTRON CUTANEOUS PO2 MONITOR 820 (April 9, 1986)

FDA data resources