Elite Electrocardiograph
FDA 510(k) K870920 · Burdick Corp.
510(k) numberK870920
Submission
- Device name
- Elite Electrocardiograph
- Applicant
- Burdick Corp.
Miltoon, WI, US - Received
- March 6, 1987
- Decision date
- April 13, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
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| K023034 | CARDIOTOUCH-3000LOS · Special | Bionet Company, Ltd. | 11/14/2002SE |
| K011328 | Cardio Care EKG-2000 12-CHANNEL ElectrocardiographLOS · Traditional | Bionet Company, Ltd. | 11/21/2001SE |
| K993616 | Cardio-Card Interpretation System ILOS · Traditional | Nasiff Assoc., Inc. | 04/10/2000SE |
| K984465 | Oxyconalpha with Option ECGLOS · Traditional | Erich Jaeger B.V. | 10/27/1999SE |
| K991014 | Case 8000 Exercise Testing SystemLOS · Traditional | General Electric Medical Systems Information Techn | 10/20/1999SE |
| K991735 | Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6, Mac Vu, Mac 8…LOS · Traditional | General Electric Medical Systems Information Techn | 08/19/1999SE |
| K990031 | Nihon Kohden ECG-9010K and ECG-9020K Cardiofax Gem and AccessoriesLOS · Traditional | Nihon Kohden America, Inc. | 04/16/1999SE |
More from Nihon Kohden America, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K952417 | Quest Exercise Stress SystemDSI · Traditional | 05/22/1996SE |
| K954267 | Burdick 200 Pulse OximeterDQA · Traditional | 05/03/1996SE |
| K946281 | Eclipse 4 ElectrocardiographLOS · Traditional | 04/23/1996SE |
| K945985 | PC Holter Scanning System Simplicity, Altair 8200, 8300, 8400DQK · Traditional | 07/03/1995SE |
| K943959 | Eclipse 4 ElectrocardiographLOS · Traditional | 05/17/1995SE |
| K942565 | Altair-Disc RecorderDQK · Traditional | 12/05/1994SE |
| K941351 | Burdick PRO2 OximeterDQA · Traditional | 10/13/1994SE |
| K942438 | Altair 6100 Cassette RecorderDSH · Traditional | 08/05/1994SE |
| K904032 | Elite II ElectrocardiographLOS · Traditional | 07/24/1991SE |
| K903565 | E560 ElectrocardiographLOS · Traditional | 07/24/1991SE |
Questions and answers
When was Elite Electrocardiograph cleared by the FDA?
Elite Electrocardiograph (K870920) received a 510(k) decision of Substantially Equivalent on April 13, 1987, 38 days after the submission was received.