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510(k) K020797

PULMO-MIST COMPRESSOR MODEL # 4323 by Nidek Medical Products, Inc. — Product Code BTI

K020797 is an FDA 510(k) premarket notification submitted by Nidek Medical Products, Inc. for the device "PULMO-MIST COMPRESSOR MODEL # 4323". The FDA issued a decision of Substantially Equivalent on May 3, 2002. The device falls under product code BTI (Compressor, Air, Portable), a Class II device regulated under 21 CFR 868.6250. Nidek Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2002
Date Received
March 12, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances by Nidek Medical Products, Inc.

  • K192693 — Nuvo Nano Portable Oxygen Concentrator (May 7, 2020)
  • K123738 — MARK 5 NUVO LITE OCSI, MARK 5 NUVO LITE STD (February 28, 2013)
  • K093308 — MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 STD (January 14, 2010)
  • K082566 — MARK 5 NUVO LITE OCSI AND STD (December 3, 2008)
  • K040892 — MARK 5 NUVO OCSI (M5C5), MODELS 505 AND 905 (April 29, 2004)
  • K032509 — MARK 5 NUVO (M5C5) (March 18, 2004)
  • K980551 — SILENZIO DELTA CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM (November 17, 1998)
  • K962492 — SILENZIO PLUS CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM (January 23, 1997)
  • K952966 — CP-90 CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM (May 7, 1996)
  • K942593 — OXYCHEK OXYGEN ANALYZER (May 3, 1995)

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