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510(k) K991644

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 1999
Date Received
May 13, 1999
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

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

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  • 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)