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510(k) K192693

Nuvo Nano Portable Oxygen Concentrator by Nidek Medical Products, Inc. — Product Code CAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 2020
Date Received
September 26, 2019
Clearance Type
Traditional
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.

  • 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)
  • 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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  • K251607 — Oxygen Concentrator (J5A) (November 21, 2025)
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  • K250625 — Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); (August 27, 2025)
  • K251130 — Portable Oxygen Concentrator (JM-P50A) (August 21, 2025)
  • K250671 — FreeStyle Comfort (AS200 / FreeStyle Comfort) (July 11, 2025)