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510(k) K802846

TCM202 TCPO2 & TCM204 TCPO2/PO2 REC. SY. by The London Co. — Product Code KLK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1980
Date Received
November 12, 1980
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 The London Co.

  • K801848 — ICA1 IONIZED CALCIUM ANALYZER (October 31, 1980)
  • K800224 — RADIOMETER ACID BASE LABORATORY-ABL-3 (February 22, 1980)
  • K780652 — HEMOGLOBIN CHECK SOLUTIONS, S2100 OSM-2 (July 27, 1978)
  • K771444 — QUALICHECK TM (August 16, 1977)
  • K771263 — RADIOMHTER OSM-2 HEMOXIMETER (August 3, 1977)
  • K760229 — ACID BASE SYSTEM, RADIOMETER AUTOMATED (August 26, 1976)

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  • 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)