Stress Testing System, Lateral Tilting
FDA 510(k) K790545 · Engineering Dynamics Corp.
510(k) numberK790545
Submission
- Device name
- Stress Testing System, Lateral Tilting
- Applicant
- Engineering Dynamics Corp.
Mchenry, IL, US - Received
- March 20, 1979
- Decision date
- June 6, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DRT – Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2300
- Specialty
- Cardiovascular
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| 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 |
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| K871494 | Uppercycle Stationary Exercise MachinesISD · Traditional | 05/06/1987SE |
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| K842108 | Universal Examination TableGZO · Traditional | 07/17/1984SE |
| K834098 | Stationary Exercise BicycleISD · Traditional | 12/27/1983SE |
| K828313 | Digital Radiography Examination Table · Traditional | 10/07/1982SE |
| K802254 | General Ultrasound Exam. TableIYN · Traditional | 11/26/1980SE |
| K790544 | Stress Testing System, Multi-PositionDRT · Traditional | 06/05/1979SE |
| K790466 | U-MatIYX · Traditional | 03/28/1979SE |
| K790499 | Multiple Pinhole Tomographic CollimoterIYX · Traditional | 03/26/1979SE |
Questions and answers
When was Stress Testing System, Lateral Tilting cleared by the FDA?
Stress Testing System, Lateral Tilting (K790545) received a 510(k) decision of Substantially Equivalent on June 6, 1979, 78 days after the submission was received.
What is the product code of K790545?
The FDA product code is DRT – Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), a Class II (moderate risk) device regulated under 21 CFR 870.2300.