Silver Mactrode
FDA 510(k) K902176 · Marquette Electronics, Inc.
510(k) numberK902176
Submission
- Device name
- Silver Mactrode
- Applicant
- Marquette Electronics, Inc.
Jupiter, FL, US - Received
- May 15, 1990
- Decision date
- September 4, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DRX – Electrode, Electrocardiograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2360
- Specialty
- Cardiovascular
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| K972199 | Signal-Averaged High Resolution P Wave AnalysisDPS · Traditional | 09/25/1997SE |
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| 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 |
Questions and answers
When was Silver Mactrode cleared by the FDA?
Silver Mactrode (K902176) received a 510(k) decision of Substantially Equivalent on September 4, 1990, 112 days after the submission was received.
What is the product code of K902176?
The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.