DRT
- Product code
- DRT
- Device name
- Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.2300
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 7
- Summaries archived here
- 7 (direct download)
- 510(k) clearances (all years, FDA)
- 339 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (7)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261286 | 2026-05-20 | Circadia Health, Inc. | The Circadia C300 System (C300) | |
| K252676 | 2026-02-03 | Circadia Health, Inc. | The Circadia C300 System (C300) | |
| K253388 | 2026-01-28 | Sleepiz AG | Sleepiz One+ (Model 2.5) | |
| K251364 | 2025-07-29 | Sleepiz AG | Sleepiz One+ (2.5) | |
| K234003 | 2024-05-30 | Circadia Technologies, Ltd. | The Circadia C200 System | |
| K232354 | 2024-03-22 | Murata Vios, Inc. | Vios Monitoring System(TM) Model 2050; Vios Central … | |
| K231733 | 2024-02-09 | Neteera Technologies , Ltd. | Neteera 130H-Plus Vital Sign Monitoring Sensor |
Official FDA classification page: DRT
Classification and pathway per current FDA publications. Data from openFDA (CC0).