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510(k) K123738

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 2013
Date Received
December 5, 2012
Clearance Type
Special
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.

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  • 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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