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510(k) K935979

CONTINUOUS POSITIVE AIRWAY PRESSURE CPAP SYSTEM by Devilbiss Health Care, Inc. — Product Code BZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 1994
Date Received
December 13, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Non-Continuous (Respirator)
Device Class
Class II
Regulation Number
868.5905
Review Panel
AN
Submission Type

Other clearances by Devilbiss Health Care, Inc.

  • K963349 — DEVILBISS 8650D (June 13, 1997)
  • K970289 — COMPRESSOR/NEBULIZER #3650 (April 15, 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)

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