Cardio P1
510(k) K231150
Cardio P1 is a medical device (FDA Class II; FDA product code DPS, Electrocardiograph) made by Bionet Co., Ltd., cleared under FDA 510(k) K231150 on 9 Nov 2023, 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 | NumberK231150 | Date9 Nov 2023 | StatusActive |
Official records
- FDA 510(k) database K231150
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DPS
- Device class
- Class II
- Regulation
- 21 CFR Part 870.2340
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K231150
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 | |||
|---|---|---|---|---|
| Cardio P1 | Cardio P1 | 08809276943972 | — | On the market |
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