510(k) K020715 ยท MKJ Automated External Defibrillators (Non-Wearable)
PHILIPS M5066A AND M5068A
| Applicant | Philips Medical Systems, Seattle WA, US |
| Decision | Substantially Equivalent - Subject to Tracking Reg., Nov 8, 2002 |
| Received | Mar 5, 2002 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K020715
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 10, 2019 | Philips North America LLC Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017 Terminated |
MKJ | None listed |
| Sep 10, 2019 | Philips North America LLC Philips HeartStart HS1 Onsite (Model M5066A) and HSI Home (Model M5068A) AED, Model 861304, HSI codeRev: E.03.063 Terminated |
MKJ | None listed |
| Aug 8, 2018 | Philips North America LLC Philips HeartStart Infant/Child SMART Pads Cartridge, Model # M5072A, UDI:00884838023758 Terminated |
MKJ | None listed |
| Mar 14, 2018 | Philips Electronics North America Corp. Philips HeartStart (HS1) Onsite/Home AED Terminated |
MKJ | None listed |
| Mar 19, 2014 | Philips 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 |
MKJ | None listed |
| Jan 4, 2013 | Philips Medical Systems North America Co. Phillips Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M5067A, and M5068A Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 Terminated |
MKJ | None listed |
| Jun 28, 2010 | Philips Medical Systems Automated External Defibrillator(AED) of brand name "Philips HeartStart HS1 OnSite" (Model number M5066A).
Device is designed for use on a person in sudden cardiac arrest who is unresponsive when sha Terminated |
MKJ | None listed |
| Jun 28, 2010 | Philips 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 |
MKJ | None listed |
| Mar 23, 2010 | Philips Medical Systems Philips Heartstart (HS1) Onsite Automated External Defibrillator (AED) Catalog number M5066A Terminated |
MKJ | None listed |
| Mar 23, 2010 | Philips Medical Systems Heartstart (HS1) Laerdal brand onsite Automated External Defibrillator, Model M5067A Terminated |
MKJ | None listed |
| Jul 9, 2008 | Philips 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 |
MKJ | None listed |
| Jul 9, 2008 | Philips Medical Systems Laerdal "HeartStart Defibrillator", model M5067A, under Laerdal brand for Laerdal Medical Corp, Wappingers Falls, NY and is sold outside the U.S. The HeartStart is an automated external defibrillator Terminated |
MKJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.