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510(k) K962079

HUMIDIFIER ADAPTER by Automatic Liquid Packaging, Inc. — Product Code BTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 1996
Date Received
May 28, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5450
Review Panel
AN
Submission Type

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  • K973829 — IRRIGATION BOTTLE (February 23, 1998)
  • K955104 — HIGH FLOW ADJUSTABLE ENTRAINMENT NEBULIZER (June 11, 1996)
  • K920306 — OPTI-MOL FILTERED PUNCTURE PIN (April 6, 1992)
  • K911770 — OPTIMOL RESPIRATORY HUMIDIFICATION SYSTEM (October 15, 1991)
  • K901762 — PREFILLED FLEXIBLE R.T. CONTAINERS W/STER. SODIUM (July 17, 1990)
  • K901362 — ACCESSORY FITMENT TO NEBULIZER SYSTEM, STERILE (June 6, 1990)
  • K901301 — STER INHAL SOLUT PREFIL BTL W/ADJUST ENTRAIN NEBUL (May 31, 1990)

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