Esort II + 400 Series Monitor
FDA 510(k) K961138 · Medical Data Electronics
510(k) numberK961138
Submission
- Device name
- Esort II + 400 Series Monitor
- Applicant
- Medical Data Electronics
Arleta, CA, US - Received
- March 21, 1996
- Decision date
- December 10, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DRO – Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5550
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
Other 510(k)s with product code DRO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K012404 | K-Defib/Pace Adult Electrode, Model KDP-85DRO · Traditional | Katecho, Inc. | 10/12/2001SE |
| K012218 | Ludlow Gradient Edge Adult & Pediatric Multifunctional ElectrodesDRO · Traditional | The Ludlow Company LP | 10/12/2001SE |
| K000660 | Escort Ii+ 400 Series (Escort Prism), Model 20400, 20401, 20403, Monitor, Models 20411…DRO · Special | Medical Data Electronics | 03/28/2000SE |
| K983232 | Padtak Pediatric Defib/Cardiovert/Pace/Monitor-Radiotransparent (2X2.25),MODEL 2602…DRO · Traditional | Tz Medical, Inc. | 09/15/1999SE |
| K983196 | Padtak Pace/Defib/Cardiovert Monitoring Electrode(S)DRO · Traditional | Tz Medical, Inc. | 09/15/1999SE |
| K974034 | Portable Intensive Care UnitDRO · Traditional | Medical Research Laboratories, Inc. | 03/02/1998SE |
| K962547 | Cardioserv PDRO · Traditional | Marquette Electronics, Inc. | 03/06/1997SE |
| K963120 | Responder 2500 Defibrillator and Cardiac Care SystemDRO · Traditional | Marquette Electronics, Inc. | 02/28/1997SE |
| K951593 | Lifepak 11DRO · Traditional | Physio-Control Corp. | 12/29/1995SE |
| K950856 | Zoll PD2000 Pacemaker/Advisory Defibrillator, Model PD2000, Zoll D2000 Advisory…DRO · Traditional | Zoll Medical Corp | 12/29/1995SE |
More from Zoll Medical Corp
| 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 |
| K992413 | Escort 100/300 Series B (Escort II) Patient MonitorDRT · Special | 08/19/1999SE |
| 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 |
| K943256 | Cardiac Output Option 39DXG · Traditional | 12/15/1994SE |
Questions and answers
When was Esort II + 400 Series Monitor cleared by the FDA?
Esort II + 400 Series Monitor (K961138) received a 510(k) decision of Substantially Equivalent on December 10, 1996, 264 days after the submission was received.
What is the product code of K961138?
The FDA product code is DRO – Pacemaker, Cardiac, External Transcutaneous (Non-Invasive), a Class II (moderate risk) device regulated under 21 CFR 870.5550.