K201581 is an FDA 510(k) clearance for the CPR BAND. This device is classified as a Aid, Cardiopulmonary Resuscitation (Class II - Special Controls, product code LIX).
Submitted by Credo (Wonju-Si, KR). The FDA issued a Cleared decision on March 6, 2021, 268 days after receiving the submission on June 11, 2020.
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 | K201581 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 11, 2020 |
| Decision Date | March 06, 2021 |
| Days to Decision | 268 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 |