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510(k) K040892

MARK 5 NUVO OCSI (M5C5), MODELS 505 AND 905 by Nidek Medical Products, Inc. — Product Code CAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2004
Date Received
April 6, 2004
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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  • 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)
  • 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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