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510(k) K961914

BACTERIA/VIRAL FILTER by Hudson Respiratory Care, Inc. — Product Code CAH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 1996
Date Received
May 17, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Bacterial, Breathing-Circuit
Device Class
Class II
Regulation Number
868.5260
Review Panel
HO
Submission Type

Other clearances by Hudson Respiratory Care, Inc.

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  • 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)
  • K955645 — CATH-GUIDE (March 12, 1996)

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