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510(k) K970289

COMPRESSOR/NEBULIZER #3650 by Devilbiss Health Care, Inc. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 1997
Date Received
January 24, 1997
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 Devilbiss Health Care, Inc.

  • K963349 — DEVILBISS 8650D (June 13, 1997)
  • K961126 — PULSE DOSE SERIES (October 21, 1996)
  • K950849 — MODEL #7354 (February 8, 1996)
  • K952491 — MODEL 7355 (January 31, 1996)
  • K952249 — JET NEBULIZER (January 30, 1996)
  • K953815 — 5 LPM OXYGEN CONCENTRATOR (November 9, 1995)
  • K952037 — 3 LPM OXYGEN CONCENTRATOR (September 6, 1995)
  • K946095 — DEVILBISS MODEL 5500 (August 24, 1995)
  • K944611 — MODEL# 7500 SURVEYOR (April 21, 1995)
  • K935979 — CONTINUOUS POSITIVE AIRWAY PRESSURE CPAP SYSTEM (November 10, 1994)

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