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510(k) K922623

NEBULIZER SYSTEM by Healthdyne, Inc. — Product Code BTI

K922623 is an FDA 510(k) premarket notification submitted by Healthdyne, Inc. for the device "NEBULIZER SYSTEM". The FDA issued a decision of Substantially Equivalent on December 1, 1992. The device falls under product code BTI (Compressor, Air, Portable), a Class II device regulated under 21 CFR 868.6250. Healthdyne, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 1992
Date Received
June 2, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Compressor, Air, Portable
Device Class
Class II
Regulation Number
868.6250
Review Panel
AN
Submission Type

Other clearances by Healthdyne, Inc.

  • K950331 — PRESSURE SUPPORT VENTILATORY ASSIST SYSTEM (PSVAS) (September 21, 1995)
  • K922106 — ALICE (July 6, 1994)
  • K942357 — H-500 ALLIANCE OXYGEN CONCENTRATOR (May 27, 1994)
  • K934502 — FLOW SPIROMETER (April 4, 1994)
  • K924146 — OH-500 OXYGEN CONCENTRATOR (January 7, 1993)
  • K910118 — DATA RECORDER (February 14, 1991)
  • K903287 — MODEL 900S APNEA/HEART MONITOR (August 17, 1990)
  • K894030 — MODEL 37 UTERINE CONTRACTION ACTIVITY MONITOR (January 22, 1990)
  • K892006 — HEALTHDYNE'S APNEA/HEART MONITOR, MODEL 900S (May 23, 1989)
  • K890150 — H-3000 OXYGEN CONCENTRATOR (January 31, 1989)

Other clearances for product code BTI

  • K131881 — OMBRA TABLE TOP COMPRESSOR (October 24, 2013)
  • K113338 — MEDICAL AIR COMPRESSOR (August 10, 2012)
  • K091871 — DK50 DS (October 23, 2009)
  • K072634 — EMG TRITON -COMP,MODEL NCA01-XXX SERIES (November 19, 2008)
  • K060781 — MEDICAL COMPRESSOR, MODELS DK50 D AND DM (October 3, 2006)
  • K051691 — MINIMATE COMPRESSOR (December 9, 2005)
  • K041781 — VENTILAIR II MEDICAL AIR COMPRESSOR (March 14, 2005)
  • K041406 — NEWPORT C250 AIR COMPRESSOR MODEL C250 (December 15, 2004)
  • K041974 — MED2000 NEBULIZER COMPRESSOR, MODELS P3, P4, P5 WITH NEBULIZER (August 24, 2004)
  • K040220 — MEDICAL AIR COMPRESSOR (June 9, 2004)

FDA data resources