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510(k) K792117

AIR-SHIELDS HEART RATE MONITOR by Narco Air-Shields — Product Code DRT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 1979
Date Received
October 26, 1979
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

  • K820114 — SYSTEM V.HEART RATE/RESPIR. RATE MONIT. (February 12, 1982)
  • 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)
  • K792118 — AIR-SHIELDS RESUSCITATORS (November 13, 1979)
  • K790552 — AS7 & AS8 MONITORS (May 1, 1979)
  • K790551 — TRANSPORT INCUBATOR (April 24, 1979)

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