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510(k) K820114

SYSTEM V.HEART RATE/RESPIR. RATE MONIT. by Narco Air-Shields — Product Code DRT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1982
Date Received
January 15, 1982
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 Air-Shields

  • K810953 — MODEL 533 PHOTOTHERAPY UNIT (April 23, 1981)
  • K810474 — PROBE COVER (March 31, 1981)
  • K802800 — NARCO AIR-SHEILDS SYS. 100 MONITOR SYS (November 24, 1980)
  • K802126 — ISOLETTE INCUBATOR C-100 (September 26, 1980)
  • K792592 — AMBU UNIVERSAL SUCTION PUMP (January 11, 1980)
  • K792499 — AMBU PAEDI ANAESTHESIA SYSTEM (December 19, 1979)
  • K792117 — AIR-SHIELDS HEART RATE MONITOR (November 13, 1979)
  • K792118 — AIR-SHIELDS RESUSCITATORS (November 13, 1979)
  • K790552 — AS7 & AS8 MONITORS (May 1, 1979)
  • K790551 — TRANSPORT INCUBATOR (April 24, 1979)

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