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510(k) K782152

VALVE, AMBU PEEP by Narco Air-Shields — Product Code BYE

K782152 is an FDA 510(k) premarket notification submitted by Narco Air-Shields for the device "VALVE, AMBU PEEP". The FDA issued a decision of SESP on December 26, 1978. The device falls under product code BYE (Attachment, Breathing, Positive End Expiratory Pressure), a Class II device regulated under 21 CFR 868.5965. Narco Air-Shields has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESP ()
Decision Date
December 26, 1978
Date Received
December 26, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Attachment, Breathing, Positive End Expiratory Pressure
Device Class
Class II
Regulation Number
868.5965
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)
  • K792118 — AIR-SHIELDS RESUSCITATORS (November 13, 1979)
  • K792117 — AIR-SHIELDS HEART RATE MONITOR (November 13, 1979)
  • K790552 — AS7 & AS8 MONITORS (May 1, 1979)

Other clearances for product code BYE

  • K160112 — Besmed PEEP Valve (April 29, 2016)
  • K133957 — DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE (April 14, 2014)
  • K133210 — B&B BUBBLER (March 28, 2014)
  • K122610 — PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES (August 5, 2013)
  • K112546 — O_TWO CPAP SYSTEM (December 27, 2011)
  • K110713 — WATERPAP VALVE (September 12, 2011)
  • K103833 — NEOPIP PATIENT CIRCUIT WITH PEEP (April 20, 2011)
  • K092029 — VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310 (August 6, 2010)
  • K090710 — MERCURY CPAP (August 20, 2009)
  • K090317 — BABI*PLUS BUBBLE PAP VALVE (May 20, 2009)

FDA data resources