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510(k) K994352

SIDE DRAFT NEB-U-MIST NEBULIZER, MODEL 41896 by Hudson Respiratory Care, Inc. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 2000
Date Received
December 23, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nebulizer (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5630
Review Panel
AN
Submission Type

Other clearances by Hudson Respiratory Care, Inc.

  • K031383 — MODEL 780 (July 7, 2003)
  • K011134 — OXYGEN SUPPLY TUBING, MODEL 1115 (June 13, 2001)
  • K011125 — NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA M (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)
  • 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)
  • K955645 — CATH-GUIDE (March 12, 1996)

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