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FDA 510(k) Applications Submitted by NATUS MEDICAL INCORPORATED
FDA 510(k) Number
Submission Date
Device Name
Applicant
K182263
08/21/2018
RetCam 3 ; RetCam Shuttle ; RetCam Portable
Natus Medical Incorporated
K111618
06/10/2011
AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION
NATUS MEDICAL INCORPORATED
K112247
08/04/2011
A BAER WITH ABAER I/O FUNCTION
NATUS MEDICAL INCORPORATED
K100683
03/10/2010
NEUROLINK IP MODEL: PK1117
NATUS MEDICAL INCORPORATED
K160305
02/04/2016
neoBLUE« LED Phototherapy System
Natus Medical Incorporated
K141446
06/02/2014
ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO HEARING SCREENER WITHOUT BARCODE SCANNER,
NATUS MEDICAL INCORPORATED
K182178
08/13/2018
neoBLUE blanket LED Phototherapy System
Natus Medical Incorporated
K103589
12/07/2010
NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM
NATUS MEDICAL INCORPORATED
K143440
12/02/2014
Natus Quantum
NATUS MEDICAL INCORPORATED
K160745
03/18/2016
neoBLUE compact LED Phototherapy System
NATUS MEDICAL INCORPORATED
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