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510(k) K792118

AIR-SHIELDS RESUSCITATORS by Narco Air-Shields — Product Code BTM

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
Ventilator, Emergency, Manual (Resuscitator)
Device Class
Class II
Regulation Number
868.5915
Review Panel
AN
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)
  • K792117 — AIR-SHIELDS HEART RATE MONITOR (November 13, 1979)
  • K790552 — AS7 & AS8 MONITORS (May 1, 1979)
  • K790551 — TRANSPORT INCUBATOR (April 24, 1979)

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