VitalScan ANS HW10
by Medeia Inc
VitalScan ANS HW10 is a Class II device made by Medeia Inc, cleared under FDA 510(k) K191266 on 15 Jan 2020 and listed in FDA GUDID since 5 Feb 2025 (UDI-DI 08690020003017), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number08690020003017 | Date5 Feb 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK191266 | Date15 Jan 2020 | StatusActive |
Official records
- AccessGUDID record 08690020003017
- FDA 510(k) database K191266
Across registries
- FDA 510(k) K191266 decided 15 Jan 2020 Active
- FDA GUDID UDI-DI 08690020003017 listed 5 Feb 2025 Listed
Timeline
- Cleared FDA 510(k) K191266
- Listed FDA GUDID 08690020003017
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- VitalScan ANS
- Generic name
- Electrocardiograph, professional, single-channel
- Model / reference
- HW10
- Primary DI / UDI-DI
- 08690020003017
- 510(k) Number
- FDA product code
- DPS, DXN, JOM
- GMDN term
- Electrocardiograph, professional, single-channel
- Device class
- Class II
- Regulation number
- 870.2340, 870.1130, 870.2780
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
Similar devices
Other devices filed under FDA product code DPS (Electrocardiograph).
- Withings Scan Monitor 2.0 by Withings
- Telemetry Software for G-2000 Electrocardiograph by Eaton Medical Group
- Siemens-Elema Sicard-P by MORTARA INSTRUMENT, INC.
- Burdick Division E-500 by MORTARA INSTRUMENT, INC.
- Clue Medical and Clue Medical Basic by Telovital GmbH Telemedizin
- HeRO by Medical Predictive Science Corp.
- Electrocardiograph (74 DPS) #YM-102 by Sanyo Electric, Inc.
- Portascope II by Mennen Greatbatch Electonics
- META III by Hittman Medical Systems
- Welch Allyn, Inc. 901129 ELI150C-JAA-AAIAB by Welch Allyn, Inc.