K123597 is an FDA 510(k) clearance for the TRUECPR COACHING DEVICE. This device is classified as a Aid, Cardiopulmonary Resuscitation (Class II - Special Controls, product code LIX).
Submitted by Physio-Control, Inc. (Redmond, US). The FDA issued a Cleared decision on April 17, 2013, 147 days after receiving the submission on November 21, 2012.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5210. 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.
| 510(k) Number | K123597 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 21, 2012 |
| Decision Date | April 17, 2013 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | LIX - Aid, Cardiopulmonary Resuscitation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5210 |
| Definition | 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 |