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510(k) K840993

TRANSCUTANEOUS 800-OXYGEN MONITORS/801 by Novametrix Medical Systems, Inc. — Product Code KLK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 1984
Date Received
March 8, 1984
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

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  • K924626 — NOVAMETRIX MODEL 510 (December 3, 1993)
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  • 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)