Cardioserv S
FDA 510(k) K962551 · Marquette Electronics, Inc.
510(k) numberK962551
Submission
- Device name
- Cardioserv S
- Applicant
- Marquette Electronics, Inc.
Milwaukee, WI, US - Received
- June 28, 1996
- Decision date
- November 19, 1996
- Decision
- Substantially Equivalent - Subject to Tracking Reg. (ST)
- Type
- Traditional 510(k)
Device classification
- Product code
- LDD – Dc-Defibrillator, Low-Energy, (Including Paddles)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5300
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
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More from Zoll Medical Corporation, World Wide Headquarters
| 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 |
| K962547 | Cardioserv PDRO · Traditional | 03/06/1997SE |
| 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 |
| 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 S cleared by the FDA?
Cardioserv S (K962551) received a 510(k) decision of Substantially Equivalent - Subject to Tracking Reg. on November 19, 1996, 144 days after the submission was received.
What is the product code of K962551?
The FDA product code is LDD – Dc-Defibrillator, Low-Energy, (Including Paddles), a Class II (moderate risk) device regulated under 21 CFR 870.5300.