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510(k) K093304

PROTEKTOR 32 by Natus Medical, Inc. — Product Code GWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 2010
Date Received
October 21, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Electrical, Evoked Response
Device Class
Class II
Regulation Number
882.1870
Review Panel
NE
Submission Type

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  • K051869 — NEOBLUE COZY LED PHOTOTHERAPY SYSTEM (October 7, 2005)
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  • K022196 — NATUS BLUE LIGHT PHOTOTHERAPY UNIT (September 19, 2002)
  • K013137 — ALGO 3 NEWBORN HEARING SCREENER (October 16, 2001)
  • K974805 — CO-STAT(TM) END TIDAL BREATH ANALYZER (March 11, 1998)
  • K935160 — MINIMUFFS (February 9, 1995)

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