ClearanceBrief
Product code MXM ยท Class 3

Cap, Cooling (Infants)

0510(k)s in 12 months (0 all time)
0recalls in 12 months (2 all time)
0recalls that name a 510(k)
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Top companies in MXM

Company510(k)sRecalls
Natus Medical Incorporated02
DateFirm and productCodeLinked 510(k)
Nov 30, 2012Natus Medical Incorporated
The product has the Catalogue/Part number 60010. Olympic Cool-Cap System is a selective head cooling system for treatment of hypoxic-ischemic encephalopathy (HIE) in infants. A cooling water cap is
Terminated
MXMNone listed
Jun 20, 2012Natus Medical Incorporated
Olympic Cool-Cap System is intended to provide treatment for neonatal hypoxic-ischemic encephalopathy (HIE). The Cool-Cap is indicated for use in full term infants (more than 36 week gestational ag
Terminated
MXMNone listed

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