Cardiac Trigger Monitor
FDA 510(k) K110987 · Ivy Biomedical Systems, Inc.
510(k) numberK110987
Submission
- Device name
- Cardiac Trigger Monitor
- Applicant
- Ivy Biomedical Systems, Inc.
Branford, CT, US - Received
- April 8, 2011
- Decision date
- July 22, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DRT – Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2300
- Specialty
- Cardiovascular
Other 510(k)s with product code DRT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261286 | The Circadia C300 System (C300)DRT · Special | Circadia Health, Inc. | 05/20/2026SE |
| K252676 | The Circadia C300 System (C300)DRT · Traditional | Circadia Health, Inc. | 02/03/2026SE |
| K253388 | Sleepiz One+ (Model 2.5)DRT · Special | Sleepiz AG | 01/28/2026SE |
| K251364 | Sleepiz One+ (2.5)DRT · Special | Sleepiz AG | 07/29/2025SE |
| K234003 | The Circadia C200 SystemDRT · Traditional | Circadia Technologies, Ltd. | 05/30/2024SE |
| K232354 | Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server…DRT · Traditional | Murata Vios, Inc. | 03/22/2024SE |
| K231733 | Neteera 130H-Plus Vital Sign Monitoring SensorDRT · Traditional | Neteera Technologies , Ltd. | 02/09/2024SE |
| K223163 | Sleepiz One+DRT · Traditional | Sleepiz AG | 08/18/2023SE |
| K212143 | Neteera 130H/131H Vital Sign Monitoring SensorDRT · Traditional | Neteera Technologies , Ltd. | 09/28/2022SE |
| K202138 | Cardiac Trigger MonitorDRT · Traditional | Ivy Biomedical Systems, Inc. | 05/14/2021SE |
More from Ivy Biomedical Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K240087 | RT Carbon ECG LeadsDSA · Traditional | 09/13/2024SE |
| K202138 | Cardiac Trigger MonitorDRT · Traditional | 05/14/2021SE |
| K203653 | MRI PPG Patient CableLNH · Traditional | 03/02/2021SE |
| K192852 | MRI ECG Patient CableLNH · Traditional | 03/28/2020SE |
| K171778 | MR Wireless Gating System, Model WGS-100LNH · Traditional | 03/14/2018SE |
| K170828 | Cardiac Trigger MonitorDRT · Abbreviated | 05/17/2017SE |
| K151781 | Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization MonitorDRT · Abbreviated | 05/27/2016SE |
| K091787 | Model 6000 Two Parameter Bedside MonitorDQA · Traditional | 10/09/2009SE |
| K091985 | Universal Physiological Measurement ModuleDRT · Special | 07/24/2009SE |
| K083854 | Cardiac Trigger, Model: CTM300DRT · Special | 02/13/2009SE |
Questions and answers
When was Cardiac Trigger Monitor cleared by the FDA?
Cardiac Trigger Monitor (K110987) received a 510(k) decision of Substantially Equivalent on July 22, 2011, 105 days after the submission was received.
What is the product code of K110987?
The FDA product code is DRT – Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), a Class II (moderate risk) device regulated under 21 CFR 870.2300.