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510(k) K082566

MARK 5 NUVO LITE OCSI AND STD by Nidek Medical Products, Inc. — Product Code CAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 2008
Date Received
September 4, 2008
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Generator, Oxygen, Portable
Device Class
Class II
Regulation Number
868.5440
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)
  • K040892 — MARK 5 NUVO OCSI (M5C5), MODELS 505 AND 905 (April 29, 2004)
  • K032509 — MARK 5 NUVO (M5C5) (March 18, 2004)
  • K020797 — PULMO-MIST COMPRESSOR MODEL # 4323 (May 3, 2002)
  • 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)

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