ClearanceBrief
510(k) K051632 ยท MKJ Automated External Defibrillators (Non-Wearable)

PHILIPS HEARTSTART FR2+ AUTOMATED EXTERNAL DEFIBRILLATOR, MODELS M3860A, M3861A, M3840A, M3841A

ApplicantPhilips Medical Systems, Seattle WA, US
DecisionSubstantially Equivalent, Oct 5, 2005
ReceivedJun 20, 2005
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K051632

DateFirm and productCodeLinked 510(k)
Oct 8, 2021Philips North America LLC
Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A
Open, Classified		 MKJNone listed
Nov 26, 2010Philips Medical Systems
HeartStart FR2+ automated external defibrillator (AED) Model M3860: Philips brand; configurable ECG on screen; configurable manual charge in advance mode.
Terminated		 MKJNone listed
Nov 26, 2010Philips Medical Systems
HeartStart FR2+ automated external defibrillator (AED) model: M3840: LAERDAL brand; configurable ECG on screen; configurable manual charge in advance mode.
Terminated		 MKJNone listed
Nov 26, 2010Philips Medical Systems
HeartStart FR2+ automated external defibrillator (AED) model: M3861: PHILIPS brand; text prompts only on screen (NO ECG); no configurable manual charge.
Terminated		 MKJNone listed
Nov 26, 2010Philips Medical Systems
HeartStart FR2+ automated external defibrillator (AED) model: M3841: LAERDAL brand; text prompts only on screen (NO ECG); no configurable manual charge.
Terminated		 MKJNone listed
Dec 8, 2009Philips Medical Systems
Heartstart FR2+ automated external defibrillator Models M3860A and M3840A are equipped with an ECG Module. M3860A is under the Philips label and M3840A is under the Laerdal label.
Terminated		 MKJNone listed
Dec 8, 2009Philips Medical Systems
Heartstart FR2+ automated external defibrillator models M3861A and M3841A are NOT equipped with the ECG Module. Model M3861A is under the Philips label and M3841A is under the Laerdal label.
Terminated		 MKJNone listed

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