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510(k) K944301

HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR CATALOG NUMBERS: 5360 THROUGH 5380 by Hudson Respiratory Care, Inc. — Product Code BTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 1994
Date Received
September 6, 1994
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 Hudson Respiratory Care, Inc.

  • K031383 — MODEL 780 (July 7, 2003)
  • K011125 — NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA M (June 13, 2001)
  • K011134 — OXYGEN SUPPLY TUBING, MODEL 1115 (June 13, 2001)
  • K010402 — SMOOTH-FLO CIRCUIT (March 14, 2001)
  • K001213 — CONCHATHERM 2000 HUMIDIFICATION SYSTEM, MODELS 500-00, -10, -20, -30, -40, -50, (November 3, 2000)
  • K993355 — HUDSON RCI CONCHA COLUMN, CAT. NO. 385-40 AND HUDSON RCI CIRCUIT, CAT. NO. 780-4 (May 24, 2000)
  • K994352 — SIDE DRAFT NEB-U-MIST NEBULIZER, MODEL 41896 (March 22, 2000)
  • K964719 — HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR (February 21, 1997)
  • K961150 — DUAL LUMEN OXYGEN DELIVERY GAS SAMPLING CANNULA (September 10, 1996)
  • K961914 — BACTERIA/VIRAL FILTER (August 14, 1996)

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  • K181583 — Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resu (December 7, 2018)
  • K170663 — Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremoun (May 11, 2018)
  • K152931 — Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR (August 29, 2016)
  • K132172 — NEONATALIE RESUSCITATOR (January 15, 2015)
  • K112852 — BABI PLUS NEONATAL RESUSCITATION BAG (January 13, 2012)