Eventmaster 3 Holter Event Scanner
FDA 510(k) K821173 · Instruments For Cardiac Research
510(k) numberK821173
Submission
- Device name
- Eventmaster 3 Holter Event Scanner
- Applicant
- Instruments For Cardiac Research
Mchenry, IL, US - Received
- April 26, 1982
- Decision date
- May 18, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DSF – Recorder, Paper Chart
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 870.2810
- Specialty
- Cardiovascular
Other 510(k)s with product code DSF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K910871 | Edentec Digital Charter Model 3710DSF · Traditional | Edentec Corp. | 08/29/1991SE |
| K912929 | Dash IVDSF · Traditional | Astro-Med, Inc. | 08/13/1991SE |
| K905856 | Model 556 MonitorDSF · Traditional | Ge Medical Systems Information Technologies | 01/11/1991SE |
| K902586 | Gri Lasergraph(Tm) ECG PaperDSF · Traditional | Gri Medical Products, Inc. | 06/22/1990SE |
| K902230 | Colorado Color Imaging RecorderDSF · Traditional | Honeywell, Inc. | 06/19/1990SE |
| K901385 | Gabriel Medical CLS Thermal RecorderDSF · Traditional | Gabriel Medical, Inc. | 05/09/1990SE |
| K895111 | Type 9541 Recorder, Paper ChartDSF · Traditional | S & W Medico Teknik | 01/26/1990SE |
| K894922 | WR3500 and WR3600 Series RecordersDSF · Traditional | Western Graphtec | 01/26/1990SE |
| K894736 | MT96000 Paper Chart RecorderDSF · Traditional | Astro-Med, Inc. | 12/13/1989SE |
| K894607 | PAQ10 Paper Chart RecorderDSF · Traditional | Protocol Systems, Inc. | 10/26/1989SE |
More from Protocol Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K834397 | Holter Cardiography Sys 6201DSI · Traditional | 04/17/1984SE |
| K820856 | Eventmaster 2DSI · Traditional | 04/29/1982SE |
| K820011 | CardiostressDPS · Traditional | 01/22/1982SE |
| K812920 | Event MasterDSH · Traditional | 12/02/1981SE |
| 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 Eventmaster 3 Holter Event Scanner cleared by the FDA?
Eventmaster 3 Holter Event Scanner (K821173) received a 510(k) decision of Substantially Equivalent on May 18, 1982, 22 days after the submission was received.
What is the product code of K821173?
The FDA product code is DSF – Recorder, Paper Chart, a Class I (low risk) device regulated under 21 CFR 870.2810.