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510(k) K791559

ROCHE SENSOR ADAPTOR by Roche Medical Electronics, Inc. — Product Code KLK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 1979
Date Received
August 17, 1979
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 Roche Medical Electronics, Inc.

  • K791037 — FETASONDE LABOR STATUS DISPLAY (September 4, 1979)
  • K791038 — FETASONDE UTERINE ACTIVITY MONITOR (September 4, 1979)
  • K791036 — FETASONDE UTERINE WORK MONITOR (September 4, 1979)
  • K791035 — FETASONDE FETAL ACTIVITY MONITOR (September 4, 1979)
  • K791039 — FETASONDE FETAL HEART RATE VARIABILITY (September 4, 1979)
  • K790761 — FETASONDE MODEL 2108 (June 1, 1979)
  • K790421 — ROCHE LACTATE ANALYZER 640 (May 15, 1979)
  • K782088 — MONITOR, HEART RATE MODEL 105 (January 4, 1979)
  • K782089 — MONITOR, HEART RATE MODEL 103 (January 4, 1979)
  • K781271 — MONITOR, PO2, INTRAVASCULAR (October 12, 1978)

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  • 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)