ClearanceBrief
510(k) K040904 ยท NSA Over-The-Counter Automated External Defibrillator

PHILIPS HEARTSTART HOME DEFIBRILLATOR, MODEL M5068A

ApplicantPhilips Medical Systems, Seattle WA, US
DecisionSubstantially Equivalent, Sep 16, 2004
ReceivedApr 7, 2004
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K040904

DateFirm and productCodeLinked 510(k)
Sep 10, 2019Philips North America LLC
Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017
Terminated		 MKJNone listed
Sep 10, 2019Philips North America LLC
Philips HeartStart HS1 Onsite (Model M5066A) and HSI Home (Model M5068A) AED, Model 861304, HSI codeRev: E.03.063
Terminated		 MKJNone listed
Mar 19, 2014Philips Medical Systems North America Inc.
Philips HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs). Product Usage: The models M5066A, M5067A, and M5068A are designed for use on a person in sudden cardiac arrest who
Terminated		 MKJNone listed
Jun 28, 2010Philips Medical Systems
Automated External Defibrillator (AED) of brand name "Philips HeartStart HS1 Home" (Model Number M5068A). Device is designed for use on a person in sudden cardiac arrest who is unresponsive when sha
Terminated		 MKJNone listed
Mar 23, 2010Philips Medical Systems
Heartstart HS1 Defibrillator Model M5068A
Terminated		 NSANone listed
Jul 9, 2008Philips Medical Systems
Philips defibrillator, model M5066A. Sold in the US by Philips as an OTC under the brand name Philips "HeartStart On Site Defibrillator" and outside the U.S. by Philips with the brand name Philips "H
Terminated		 MKJNone listed
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		 NSANone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.