Cardio10
510(k) K220535
Cardio10 is a medical device (FDA Class II; FDA product code DPS, Electrocardiograph) made by Bionet Co., Ltd., cleared under FDA 510(k) K220535 on 15 Nov 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 | NumberK220535 | Date15 Nov 2022 | StatusActive |
Official records
- FDA 510(k) database K220535
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- Withdrawn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
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