VitalScan ANS
by Medeia Inc
510(k) K191266
VitalScan ANS is a Class II device made by Medeia Inc, cleared under FDA 510(k) K191266 on 15 Jan 2020, 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 | NumberK191266 | Date15 Jan 2020 | StatusActive |
Official records
- FDA 510(k) database K191266
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JOM
- FDA applicant
- Medeia, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 870.2780
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K191266
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 | |||
|---|---|---|---|---|
| VitalScan ANS HW10 | HW10 | 08690020003017 | — | On the market |
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