Cardiotouch-3000
510(k) K023034
Cardiotouch-3000 is a medical device (FDA product code LOS) made by Bionet Co., Ltd., cleared under FDA 510(k) K023034 on 14 Nov 2002, active as of 13 Nov 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 | NumberK023034 | Date14 Nov 2002 | StatusActive |
Official records
- FDA 510(k) database K023034
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LOS
- FDA applicant
- Bionet Company, Ltd.
- Advisory committee
- Unknown
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K023034
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 | |||
|---|---|---|---|---|
| CardioTouch3000 | CardioTouch3000 | 08809276943545 | — | On the market |
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