Lifepak 11
FDA 510(k) K951593 · Physio-Control Corp.
510(k) numberK951593
Submission
- Device name
- Lifepak 11
- Applicant
- Physio-Control Corp.
Redmond, WA, US - Received
- April 6, 1995
- Decision date
- December 29, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DRO – Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5550
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
Other 510(k)s with product code DRO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K012404 | K-Defib/Pace Adult Electrode, Model KDP-85DRO · Traditional | Katecho, Inc. | 10/12/2001SE |
| K012218 | Ludlow Gradient Edge Adult & Pediatric Multifunctional ElectrodesDRO · Traditional | The Ludlow Company LP | 10/12/2001SE |
| K000660 | Escort Ii+ 400 Series (Escort Prism), Model 20400, 20401, 20403, Monitor, Models 20411…DRO · Special | Medical Data Electronics | 03/28/2000SE |
| K983232 | Padtak Pediatric Defib/Cardiovert/Pace/Monitor-Radiotransparent (2X2.25),MODEL 2602…DRO · Traditional | Tz Medical, Inc. | 09/15/1999SE |
| K983196 | Padtak Pace/Defib/Cardiovert Monitoring Electrode(S)DRO · Traditional | Tz Medical, Inc. | 09/15/1999SE |
| K974034 | Portable Intensive Care UnitDRO · Traditional | Medical Research Laboratories, Inc. | 03/02/1998SE |
| K962547 | Cardioserv PDRO · Traditional | Marquette Electronics, Inc. | 03/06/1997SE |
| K963120 | Responder 2500 Defibrillator and Cardiac Care SystemDRO · Traditional | Marquette Electronics, Inc. | 02/28/1997SE |
| K961138 | Esort II + 400 Series MonitorDRO · Traditional | Medical Data Electronics | 12/10/1996SE |
| K950856 | Zoll PD2000 Pacemaker/Advisory Defibrillator, Model PD2000, Zoll D2000 Advisory…DRO · Traditional | Zoll Medical Corp | 12/29/1995SE |
More from Zoll Medical Corp
| 510(k) | Device | Decision |
|---|---|---|
| K253099 | LIFEPAK 15 AC Power Adapter (41577-000333)MPD · Special | 10/14/2025SE |
| K240156 | LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV…DSA · Traditional | 04/30/2024SE |
| K182503 | Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitorsLDD · Traditional | 06/03/2019SE |
| K142430 | LIFEPAK 15 monitor/defibrillatorMKJ · Traditional | 12/19/2014SE |
| K130454 | Lifepak 20 Defibrillator/Monitor, Lifepak 20E Defibrillator/MonitorMKJ · Traditional | 08/21/2013SE |
| K123597 | Truecpr Coaching DeviceLIX · Traditional | 04/17/2013SE |
| K122600 | Lifepak 1000 DefibrillatorMKJ · Traditional | 10/11/2012SE |
| K103567 | Lifepak 15 Monitor/DefibrillatorMKJ · Traditional | 03/22/2011SE |
| K102972 | Lifepak 12MKJ · Special | 12/22/2010SE |
| K102757 | Lifenet SystemMSX · Special | 11/05/2010SE |
Questions and answers
When was Lifepak 11 cleared by the FDA?
Lifepak 11 (K951593) received a 510(k) decision of Substantially Equivalent on December 29, 1995, 267 days after the submission was received.
What is the product code of K951593?
The FDA product code is DRO – Pacemaker, Cardiac, External Transcutaneous (Non-Invasive), a Class II (moderate risk) device regulated under 21 CFR 870.5550.