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510(k) K894244

DEVILBISS MODEL 8500D AND 8500D-608 by Devilbiss Health Care, Inc. — Product Code CCQ

K894244 is an FDA 510(k) premarket notification submitted by Devilbiss Health Care, Inc. for the device "DEVILBISS MODEL 8500D AND 8500D-608". The FDA issued a decision of Substantially Equivalent on October 6, 1989. The device falls under product code CCQ (Nebulizer, Medicinal, Non-Ventilatory (Atomizer)), a Class I device regulated under 21 CFR 868.5640. Devilbiss Health Care, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 1989
Date Received
June 21, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
Device Class
Class I
Regulation Number
868.5640
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)

Other clearances for product code CCQ

  • K972397 — EZ SPRAY (September 23, 1997)
  • K964956 — E-Z SPACER MASK (SMALL) (April 23, 1997)
  • K961894 — MDI TUTOR (August 14, 1996)
  • K961455 — MEDSHIELD/AEROCHAMBER (July 25, 1996)
  • K960593 — SMARTMIST ASTHMA MANAGMENT SYSTEM, SMARTMIST, MODEL NUMBER SM-100/SMARTMIST SPIR (May 10, 1996)
  • K922033 — SALINE SOLUTION- STERILE (July 21, 1992)
  • K900576 — MODIFIED AEROCHAMBER WITH MASK (May 13, 1991)
  • K900557 — MODIFIED AEROCHAMBER M.V. AEROSOL HOLDING CHAMBER (April 10, 1991)
  • K895115 — FRANK INHALER THERMAL S (May 18, 1990)
  • K894215 — EVOLUTION ULTRASONIC (April 16, 1990)

FDA data resources