Submission Details
| 510(k) Number | K201581 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
CPR BAND
Mar 2021
Decision
268d
Days
Class 2
Risk
About This 510(k) Submission
K201581 is an FDA 510(k) clearance for the CPR BAND, 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 review panel. Regulated under 21 CFR 870.5210.
Device Classification
| 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 |
Manufacturer
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