FDA 510(k) K233253, eCARTv5 Clinical Deterioration Suite (“eCART”), by Agilemd, Inc.
FDA 510(k) K233253, eCARTv5 Clinical Deterioration Suite (“eCART”), by Agilemd, Inc.
| 510(k) Number | K233253 |
| Device Classification Name | Medium-Term Adjunctive Predictive Cardiovascular Indicator |
| Device Name | eCARTv5 Clinical Deterioration Suite (“eCART”) |
| Applicant | Agilemd, Inc. 2261 Market St. #4378 San Francisco, CA 94114 |
| Regulation Number | 870.221 |
| Classification Product Code | QNL |
| Date Received | 09/28/2023 |
| Decision Date | 06/21/2024 |
| Decision | Substantially Equivalent (SESE) |
| Regulation Medical Specialty | Cardiovascular |
| 510k Review Panel | Cardiovascular |
| Type | Traditional |
| Reviewed by Third Party | No |
| Combination Product | No |
| Total Pages | 4762 |
| Redacted Pages | 4422 |
| Unredacted Pages | 340 |
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