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510(k) K831460

AS 30/TCP MODULE by Narco Scientific — Product Code KLK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 1983
Date Received
May 6, 1983
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 Narco Scientific

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  • K831430 — AIR SHIELDS AS-100 MONIORING SYS-AS105 (September 12, 1983)
  • K830123 — DISP. YANKAVER SURG. SUCTION INSTRUMENT (June 8, 1983)
  • K831028 — TI-1000 TRANSPORT INCUBATOR (May 9, 1983)
  • K823899 — INFANT CARE SYSTEM (April 14, 1983)
  • K830680 — AIR-SHIELDS VENTIMETER VENTILATOR-CONTR (April 8, 1983)
  • K830654 — INFUSION PUMP RETROGRADE EXTEN. AS 715 (March 24, 1983)

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