Cardioserv P
FDA 510(k) K962547 · Marquette Electronics, Inc.
510(k) numberK962547
Submission
- Device name
- Cardioserv P
- Applicant
- Marquette Electronics, Inc.
Milwaukee, WI, US - Received
- June 28, 1996
- Decision date
- March 6, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| K963120 | Responder 2500 Defibrillator and Cardiac Care SystemDRO · Traditional | Marquette Electronics, Inc. | 02/28/1997SE |
| K961138 | Esort II + 400 Series MonitorDRO · Traditional | Medical Data Electronics | 12/10/1996SE |
| 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 |
|---|---|---|
| K971868 | Impact (Informing Mobile Personnel and Care Tracking) Pager SystemMSX · Traditional | 11/13/1997SE |
| K971683 | Wireless Lan (Local Area Network) - Wireless EthernetMSX · Traditional | 10/22/1997SE |
| K972199 | Signal-Averaged High Resolution P Wave AnalysisDPS · Traditional | 09/25/1997SE |
| K963120 | Responder 2500 Defibrillator and Cardiac Care SystemDRO · Traditional | 02/28/1997SE |
| K962827 | Alarm Display Unit/Pager-Lan System (Adu)DSI · Traditional | 02/24/1997SE |
| K964750 | Eagle 4000 Patient MonitorLOS · Traditional | 02/21/1997SE |
| K962551 | Cardioserv SLDD · Traditional | 11/19/1996ST |
| K960418 | Eagle Patient MonitorDSI · Traditional | 10/02/1996SE |
| K960272 | Eagle 3000/3100 Patient MonitorMLD · Traditional | 10/02/1996SE |
| K961139 | Eagle Patient Monitor Model 3000/3100DSI · Traditional | 08/09/1996SE |
Questions and answers
When was Cardioserv P cleared by the FDA?
Cardioserv P (K962547) received a 510(k) decision of Substantially Equivalent on March 6, 1997, 251 days after the submission was received.
What is the product code of K962547?
The FDA product code is DRO – Pacemaker, Cardiac, External Transcutaneous (Non-Invasive), a Class II (moderate risk) device regulated under 21 CFR 870.5550.