Escort 100/300 Series B (Escort II) Patient Monitor
FDA 510(k) K992413 · Medical Data Electronics
510(k) numberK992413
Submission
- Device name
- Escort 100/300 Series B (Escort II) Patient Monitor
- Applicant
- Medical Data Electronics
Arleta, CA, US - Received
- July 20, 1999
- Decision date
- August 19, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K014294 | Modification to Escort Ii+ 400 Series 9ESCORT Prism) Monitor, Models 20400, 20401…DQA · Special | 01/25/2002SE |
| K012336 | Modification To:Escort Vision Central Station Telemetry System, Model 20500DSI · Special | 10/03/2001SE |
| K000660 | Escort Ii+ 400 Series (Escort Prism), Model 20400, 20401, 20403, Monitor, Models 20411…DRO · Special | 03/28/2000SE |
| K992411 | Escort Ii+ 400 Series (Escort Prism) MonitorDRT · Special | 08/18/1999SE |
| K982104 | Escort-Link Central Station Monitor Model 20500MLD · Special | 11/25/1998SE |
| K970763 | Modular Telemetry System (MTS) Option for the Mde Escort II MonitorDQA · Traditional | 07/14/1997SE |
| K970011 | Escort II Clinical Thermometry Module (CTM)FLL · Traditional | 07/09/1997SE |
| K970012 | Escort Link Central Station MonitorDSI · Traditional | 06/26/1997SE |
| K961138 | Esort II + 400 Series MonitorDRO · Traditional | 12/10/1996SE |
| K943256 | Cardiac Output Option 39DXG · Traditional | 12/15/1994SE |
Questions and answers
When was Escort 100/300 Series B (Escort II) Patient Monitor cleared by the FDA?
Escort 100/300 Series B (Escort II) Patient Monitor (K992413) received a 510(k) decision of Substantially Equivalent on August 19, 1999, 30 days after the submission was received.
What is the product code of K992413?
The FDA product code is DRT – Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), a Class II (moderate risk) device regulated under 21 CFR 870.2300.