Innovo
Innovo (101759) is a medical device (FDA Class II; FDA product code DRG, Transmitters And Receivers, Physiological Signal, Radiofrequency) made by Scottcare Corporation, the, cleared under FDA 510(k) K050778 on 13 Apr 2005 and listed in FDA GUDID since 19 Sep 2016 (UDI-DI 00856298006060), active as of 21 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 | Number00856298006060 | Date19 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK050778 | Date13 Apr 2005 | StatusActive |
Official records
- AccessGUDID record 00856298006060
- FDA 510(k) database K050778
Across registries
- FDA 510(k) K050778 decided 13 Apr 2005 Active
- FDA GUDID UDI-DI 00856298006060 listed 19 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K050778
- Listed FDA GUDID 00856298006060
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Electrocardiography telemetric monitoring system transmitter
- Model / Ref / Catalog
- Innovo, 101759
- Primary DI / UDI-DI
- 00856298006060
- 510(k) Number
- FDA product code
- DRG
- GMDN term
- Electrocardiography telemetric monitoring system transmitter
- Device class
- Class II
- Regulation number
- 870.2910
- GUDID distribution status
- In Commercial Distribution
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