Home / 510(k) Clearances / K811836

510(k) K811836

PO-200 BLOOD OXYGEN MONITOR by Sumitomo Electric Industries, Inc. — Product Code KLK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1981
Date Received
June 30, 1981
Clearance Type
Traditional
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 Sumitomo Electric Industries, Inc.

  • K852959 — PO-510 TCPO2 MONITOR (November 29, 1985)

Other clearances for product code KLK

  • K003943 — MICROGAS 7650 TRANSCUTANEOUS MONITOR (May 4, 2001)
  • 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)