Medsim 300 Patient Simulator
FDA 510(k) K935817 · Dynatech/Nevada, Inc.
510(k) numberK935817
Submission
- Device name
- Medsim 300 Patient Simulator
- Applicant
- Dynatech/Nevada, Inc.
Washington, DC, US - Received
- December 2, 1993
- Decision date
- January 18, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K942546 | Cufflink Non-Invasive Blood Pressure AnalyzerDXN · Traditional | 01/27/1995SE |
| K934254 | Impulse 3000 Defibrillator AnalyzerDRL · Traditional | 11/23/1993SE |
| K897074 | Model 215M Patient SimulatorDSI · Traditional | 05/17/1990SE |
| K897029 | Model ECG100 SimulatorDPS · Traditional | 04/26/1990SE |
| K897096 | Model 404A I.V. Infusion Pump AnalyzerFRN · Traditional | 03/15/1990SE |
Questions and answers
When was Medsim 300 Patient Simulator cleared by the FDA?
Medsim 300 Patient Simulator (K935817) received a 510(k) decision of Substantially Equivalent on January 18, 1994, 47 days after the submission was received.
What is the product code of K935817?
The FDA product code is DRT – Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), a Class II (moderate risk) device regulated under 21 CFR 870.2300.