CardioGraphe
510(k) K213465
CardioGraphe is a Class II device made by Arineta, Ltd., cleared under FDA 510(k) K213465 on 2 Dec 2022, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK213465 | Date2 Dec 2022 | StatusActive |
Official records
- FDA 510(k) database K213465
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JAK
- FDA applicant
- Arineta , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1750
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K213465
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| SpotLight | SpotLight | 07290016484014 | — | On the market |
| SpotLight Duo | SpotLight | 07290016484021 | — | On the market |
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