Event Master
FDA 510(k) K812920 · Instruments For Cardiac Research
510(k) numberK812920
Submission
- Device name
- Event Master
- Applicant
- Instruments For Cardiac Research
Mchenry, IL, US - Received
- October 19, 1981
- Decision date
- December 2, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DSH – Recorder, Magnetic Tape, Medical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2800
- Specialty
- Cardiovascular
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| K233906 | S-Patch (S-Patch ExL)DSH · Special | Wellysis Corp. | 02/16/2024SE |
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| K233110 | Carnation Ambulatory MonitorDSH · Traditional | Bardy Diagnostics, Inc. | 11/22/2023SE |
More from Bardy Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K834397 | Holter Cardiography Sys 6201DSI · Traditional | 04/17/1984SE |
| K821173 | Eventmaster 3 Holter Event ScannerDSF · Traditional | 05/18/1982SE |
| K820856 | Eventmaster 2DSI · Traditional | 04/29/1982SE |
| K820011 | CardiostressDPS · Traditional | 01/22/1982SE |
| K801903 | Series 4000 Stress & Exercise SystemDSI · Traditional | 03/11/1981SE |
| K771374 | Scanner Trend SystemDSI · Traditional | 08/04/1977SE |
| K770705 | Cardiac Acquisition System, Icr 2001DQK · Traditional | 06/02/1977SE |
Questions and answers
When was Event Master cleared by the FDA?
Event Master (K812920) received a 510(k) decision of Substantially Equivalent on December 2, 1981, 44 days after the submission was received.
What is the product code of K812920?
The FDA product code is DSH – Recorder, Magnetic Tape, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2800.