HolterCare
HolterCare (100087) is a medical device (FDA Class II; FDA product code DQK, Computer, Diagnostic, Programmable) made by Scottcare Corporation, the, cleared under FDA 510(k) K042463 on 22 Sep 2004 and listed in FDA GUDID since 19 Sep 2016 (UDI-DI 00856298006169), active as of 8 Jun 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 | Number00856298006169 | Date19 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK042463 | Date22 Sep 2004 | StatusActive |
Official records
- AccessGUDID record 00856298006169
- FDA 510(k) database K042463
Across registries
- FDA 510(k) K042463 decided 22 Sep 2004 Active
- FDA GUDID UDI-DI 00856298006169 listed 19 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K042463
- Listed FDA GUDID 00856298006169
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Electrocardiographic long-term ambulatory recording analyser application software
- Model / Ref / Catalog
- HolterCare, 100087
- Primary DI / UDI-DI
- 00856298006169
- 510(k) Number
- FDA product code
- DQK
- GMDN term
- Electrocardiographic long-term ambulatory recording analyser application software
- Device class
- Class II
- Regulation number
- 870.1425
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Electrocardiographic long-term ambulatory recording analyser application software.