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510(k) K013137

ALGO 3 NEWBORN HEARING SCREENER by Natus Medical, Inc. — Product Code GWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 2001
Date Received
September 19, 2001
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Auditory, Evoked Response
Device Class
Class II
Regulation Number
882.1900
Review Panel
NE
Submission Type

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  • K073665 — ALGO 5 NEWBORN HEARING SCREENER (January 25, 2008)
  • K051869 — NEOBLUE COZY LED PHOTOTHERAPY SYSTEM (October 7, 2005)
  • K030823 — ALGO 3I NEWBORN HEARING SCREENER (April 9, 2003)
  • K022196 — NATUS BLUE LIGHT PHOTOTHERAPY UNIT (September 19, 2002)
  • K974805 — CO-STAT(TM) END TIDAL BREATH ANALYZER (March 11, 1998)
  • K935160 — MINIMUFFS (February 9, 1995)

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  • K211147 — ALGO 7i (October 14, 2021)
  • K193033 — GSI Audera Pro (April 24, 2020)
  • K163326 — SmartEP (September 29, 2017)
  • K162037 — Eclipse with VEMP (March 23, 2017)
  • K143670 — ICS CHARTR EP 200 WITH VEMP (October 23, 2015)
  • K141446 — ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO H (August 22, 2014)
  • K132957 — MADSEN ACCUSCREEN TYPE 1077 (February 27, 2014)