Company ยท US
Medtronic Emergency Response Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2004 to 2007. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
21recalls (0 in 12 months)
15recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 26, 2007 | K063510 | LIFEPAK 12 DEFIBRILLATOR/MONITOR Medtronic Emergency Response Systems, Inc. | MKJ |
| Dec 22, 2006 | K063119 | LIFEPAK 20 DEFIBRILLATOR/ MONITOR Medtronic Emergency Response Systems, Inc. | MKJ |
| Feb 17, 2006 | K052057 | LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR Medtronic Emergency Response Systems, Inc. | MKJ |
| Jan 20, 2006 | K052854 | LIFENET EXCHANGE SYSTEM Medtronic Emergency Response Systems, Inc. | MSX |
| Dec 22, 2005 | K042404 | LIFEPAK, MODEL 1000 Medtronic Emergency Response Systems, Inc. | MKJ |
| Jul 1, 2004 | K041459 | LIFEPAK 12 DEFIBRILLATOR/MONITOR Medtronic Emergency Response Systems, Inc. | MKJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 4, 2007 | Medtronic Emergency Response Systems, Inc. biphasic LIFEPAK 500 automated external defibrillators (AEDs) with software version 4.4 or lower; Part Nos. 3011790-XXXXXX, D3100790-XXXXXX, and U3011790-XXXXXX . (XXXX indicates various non-contiguo Terminated |
MKT | K955854 |
| Jul 4, 2007 | Medtronic Emergency Response Systems, Inc. Batteries used with the LIFEPAK 20 defibrillator/monitor Terminated |
MJK | None listed |
| Jul 4, 2007 | Medtronic Emergency Response Systems, Inc. LIFEPAK 20 defibrillator/monitor. The device is an AC powered defibrillator device with battery backup. The defibrillators are primarily used by healthcare providers in device user facilities such a Terminated |
MJK | K012274 |
| Jun 21, 2007 | Medtronic Emergency Response Systems, Inc. LIFEPAK EXPRESS defibrillator Terminated |
MKJ | K011144 |
| Jun 21, 2007 | Medtronic Emergency Response Systems, Inc. LIFEPAK CR Plus defibrillator Terminated |
MKJ | K011144 |
| Jun 9, 2007 | Medtronic Emergency Response Systems, Inc. LIFEPAK 20 defibrillator/monitor. The device is an AC powered defibrillator device with battery backup. The defibrillators are primarily used by healthcare providers in device user facilities such as Terminated |
MJK | K012274 |
| Mar 29, 2007 | Medtronic Emergency Response Systems, Inc. LIFEPAK CR Plus defibrillator. The device is a battery operated, portable automated external defibrillator (AED). The devices are designed for non-professional users and are primarily used in public Terminated |
MKJ | K011144 |
| Dec 19, 2006 | Medtronic Emergency Response Systems, Inc. LIFEPAK 20 automatic external defibrillator Terminated |
LDD | K012274 |
| Sep 13, 2006 | Medtronic Emergency Response Systems, Inc. LIFEPAK 20 external defibrillator/monitor Terminated |
LDD | K012274 |
| Apr 4, 2006 | Medtronic Emergency Response Systems, Inc. LIFEPAK 20 defibrillator/monitor Terminated |
LDD | K012274 |
| Apr 4, 2006 | Medtronic Emergency Response Systems, Inc. LIFEPAK 12 defibrillator/monitor Terminated |
MKJ | K010918 |
| Feb 23, 2006 | Medtronic Emergency Response Systems, Inc. LIFEPAK EXPRESS defibrillator Terminated |
MKJ | None listed |
| Feb 23, 2006 | Medtronic Emergency Response Systems, Inc. LIFEPAK CR Plus defibrillator Terminated |
MKJ | None listed |
| Feb 22, 2006 | Medtronic Emergency Response Systems, Inc. LIFEPAK 500 automated external defibrillator (AED) Terminated |
MKJ | None listed |
| Nov 2, 2005 | Medtronic Emergency Response Systems, Inc. standard (hard) paddles used with the LIFEPAK 12 defibrillator/monitor series. Terminated |
LDD | K012274 |
| Nov 2, 2005 | Medtronic Emergency Response Systems, Inc. QUIK-COMBO pacing/defibrillation/ECG (therapy) cables used with the LIFEPAK 12 defibrillator/monitor series. Terminated |
LDD | K012274 |
| Oct 4, 2005 | Medtronic Emergency Response Systems, Inc. Hard shell carry case for the LIFEPAK CR Plus. Terminated |
MKJ | None listed |
| Oct 4, 2005 | Medtronic Emergency Response Systems, Inc. Hard shell carry case for the LIFEPAK 500 AED. Terminated |
MKJ | K010918 |
| Jul 13, 2005 | Medtronic Emergency Response Systems, Inc. LIFEPAK 20 defbrillator/monitor Terminated |
LDD | K012274 |
| Mar 10, 2005 | Medtronic Emergency Response Systems, Inc. LIFEPAK 500 AED. Terminated |
MKJ | None listed |
| Feb 3, 2005 | Medtronic Emergency Response Systems, Inc. LIFEPAK 12 defibrillator/ monitors biphasic Terminated |
MKJ | K040775 K991910 |