Cardio 7
510(k) K113306
Cardio 7 is a medical device (FDA Class II; FDA product code DPS, Electrocardiograph) made by Bionet Co., Ltd., cleared under FDA 510(k) K113306 on 16 Jul 2012, 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 | NumberK113306 | Date16 Jul 2012 | StatusActive |
Official records
- FDA 510(k) database K113306
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- Withdrawn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 K113306
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 | |||
|---|---|---|---|---|
| Cardio7 | Cardio7 | 08809276943552 | — | On the market |
Similar devices
Other devices filed under FDA product code DPS (Electrocardiograph).
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- Welch Allyn, Inc. 901132 ELI280-LDX-ADCBX by Welch Allyn, Inc.
- Fastrace III ECG Electrode by Conmed Andover Medical, Inc.
- CARDIO-SLIDECOMP by Creative Instruments
- physIQ Heart Rhythm and Respiration Module by PHYSIQ, INC
- Spacelabs Series 1000 by Spacelabs, Inc.
- Radius VSM 4888 by MASIMO CORPORATION