FDA-Device2015-10-28Class II
Natus neoBLUE 3 Phototherapy system or Neonatal Phototherapy, Catalogue Part Number: 010066; Top Assembly Part Number: 001103
Natus Medical Incorporated
Hazard
The neoBLUE Instruction For Use (IFU) and Service Manuals for the neoBLUE 3 were revised to show the cleared intensity statement settings so the output intensity aligns precisely with the information listed in the cleared 510(k) submission.
Sold states
Nationwide Distribution.
Affected count
4560 units
Manufactured in
5900 1st Ave S, N/A, Seattle, WA, United States
Products
Natus neoBLUE 3 Phototherapy system or Neonatal Phototherapy, Catalogue Part Number: 010066; Top Assembly Part Number: 001103
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0149-2016Don't want to check this manually?
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