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510(k) K896090

DEVILBISS MODEL 6300D by Devilbiss Health Care, Inc. — Product Code EPN

K896090 is an FDA 510(k) premarket notification submitted by Devilbiss Health Care, Inc. for the device "DEVILBISS MODEL 6300D". The FDA issued a decision of Substantially Equivalent on November 30, 1989. The device falls under product code EPN (Pump, Nebulizer, Manual), a Class I device regulated under 21 CFR 874.5220. Devilbiss Health Care, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 1989
Date Received
October 19, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Nebulizer, Manual
Device Class
Class I
Regulation Number
874.5220
Review Panel
EN
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 EPN

  • K802430 — NEBULIZER, MEDICINAL (October 23, 1980)

FDA data resources