Heart Smart Sirona
by Datrix LLC
Heart Smart Sirona (RX93030-007) is a Class II device made by Datrix LLC, cleared under FDA 510(k) K112601 on 9 Nov 2011 and listed in FDA GUDID since 19 Dec 2017 (UDI-DI 00851074007323), 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 | GUDID listing | Number00851074007323 | Date19 Dec 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK112601 | Date9 Nov 2011 | StatusActive |
Official records
- AccessGUDID record 00851074007323
- FDA 510(k) database K112601
Across registries
- FDA 510(k) K112601 decided 9 Nov 2011 Active
- FDA GUDID UDI-DI 00851074007323 listed 19 Dec 2017 Listed
Timeline
- Cleared FDA 510(k) K112601
- Listed FDA GUDID 00851074007323
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Heart Smart
- Generic name
- Telemetric electrocardiographic ambulatory recorder
- Model / Ref / Catalog
- Sirona, RX93030-007
- Primary DI / UDI-DI
- 00851074007323
- 510(k) Number
- FDA product code
- MWJ
- GMDN term
- Telemetric electrocardiographic ambulatory recorder
- Device class
- Class II
- Regulation number
- 870.2800
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code MWJ (Electrocardiograph,Ambulatory(Without Analysis)).
- MODEL 950-12L HOLTER RECORDER WITHOUT ANALYSIS by Memtec Corporation
- SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDER by North East Monitoring, Inc.
- ASSURE Wearable ECG by Kestra Medical Technologies, Inc.
- Welch Allyn, Inc. 901142 H3PLUS-CFB-XXXXX by Welch Allyn, Inc.
- Welch Allyn, Inc. 901142 H3PLUS-CAB-XXXXX by Welch Allyn, Inc.
- CARDIOVISE ECG INTERPRETATIVE SOFTWARE by Inovise Medical, Inc.
- INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDER by Intricon Datrix Corporation
- Biotres by Biotricity, Inc.
- CARDTEL, MODEL NT-100 by Cardiac Telecommunications
- WALK400H by Et Medical Devices Spa