Ecard and Ccard
510(k) K081471
Ecard and Ccard is a Class II device made by Irhythm Technologies, Inc., cleared under FDA 510(k) K081471 on 24 Jun 2008, 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 | NumberK081471 | Date24 Jun 2008 | StatusActive |
Official records
- FDA 510(k) database K081471
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DXH
- Device class
- Class II
- Regulation
- 21 CFR Part 870.2920
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
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