Truecpr Coaching Device
FDA 510(k) K123597 · Physio-Control, Inc.
510(k) numberK123597
Submission
- Device name
- Truecpr Coaching Device
- Applicant
- Physio-Control, Inc.
Redmond, WA, US - Received
- November 21, 2012
- Decision date
- April 17, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LIX – Aid, Cardiopulmonary Resuscitation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5210
- Specialty
- Cardiovascular
CPR Aid device WITH feedback (visual, audio or both) on one or more CPR parameters (e.g., rate, depth, ventilation ratio, etc.), and contains software. Provides real-time feedback on CPR performance. Feedback can be audio, visual or both. Device contains software
Other 510(k)s with product code LIX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K201581 | CPR BandLIX · Traditional | Credo | 03/06/2021SE |
| K183348 | Reusable Silicone Cover CPRmeter 2LIX · Special | Laerdal Medical AS | 12/17/2018SE |
| K173886 | CPRmeter 2 CPR Feedback DeviceLIX · Traditional | Laerdal Medical AS | 03/23/2018SE |
| K151702 | Reusable Full Silicone CoverLIX · Special | Laerdal Medical AS | 08/13/2015SE |
| K123248 | CPR RSQ AssistLIX · Traditional | Avantech, Inc. | 12/10/2013SE |
| K122050 | Cprmeter CPR Feedback DeviceLIX · Traditional | Laerdal Medical A/S | 10/22/2012SE |
| K112660 | PocketcprLIX · Abbreviated | Zoll Medical Corp | 05/10/2012SE |
| K092408 | Rhythm of Life, Model R0901-05LIX · Traditional | Rapid Response Solutions, LLC | 10/14/2009SE |
| K071321 | PocketcprLIX · Traditional | Bio-Detek, Inc. | 09/12/2007SE |
| K010526 | Modification to the GripLIX · Traditional | Elcare Innovations, Inc. | 12/13/2001SE |
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| 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 |
| 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 |
| K093925 | Lifenet SystemMSX · Special | 01/12/2010SE |
Questions and answers
When was Truecpr Coaching Device cleared by the FDA?
Truecpr Coaching Device (K123597) received a 510(k) decision of Substantially Equivalent on April 17, 2013, 147 days after the submission was received.
What is the product code of K123597?
The FDA product code is LIX – Aid, Cardiopulmonary Resuscitation, a Class II (moderate risk) device regulated under 21 CFR 870.5210.