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510(k) K831430

AIR SHIELDS AS-100 MONIORING SYS-AS105 by Narco Scientific — Product Code DRT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1983
Date Received
May 3, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type

Other clearances by Narco Scientific

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  • K831428 — AS 1740 INTERFACE MODULE (October 14, 1983)
  • K831429 — AS 191 ECG TELEMETRY MODULE (October 14, 1983)
  • K822835 — PZ-800 VOLUME VENTILATOR (September 29, 1983)
  • K831460 — AS 30/TCP MODULE (July 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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