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Panels › Cardiovascular › Product code NSA · Class 3

Over-The-Counter Automated External Defibrillator

Regulation 870.5310

0510(k)s in 12 months (1 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
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Top companies in NSA

Company510(k)sRecalls
Philips Medical Systems12
DateFirm and productCodeLinked 510(k)
Mar 23, 2010Philips Medical Systems
Heartstart HS1 Defibrillator Model M5068A
Terminated
NSAK040904
Jul 9, 2008Philips Medical Systems
Philips "HeartStart Home" defibrillator, model M5068A and is sold in the US over the counter. The HeartStart is an automated external defibrillator for use on site and consists of a computer with di
Terminated
NSAK040904

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