Ver-Med A10017 Universal Electrode
FDA 510(k) K905489 · Vermont Medical, Inc.
510(k) numberK905489
Submission
- Device name
- Ver-Med A10017 Universal Electrode
- Applicant
- Vermont Medical, Inc.
Bellows Falls, VT, US - Received
- December 7, 1990
- Decision date
- March 21, 1991
- 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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| K100129 | Ambu Blue Sensor Neo, Ambu Blue Sensor Neo XDRX · Abbreviated | Ambu A/S | 06/11/2010SE |
| K093327 | Intco Tab ElectrodeDRX · Abbreviated | Shanghai Intco Electrode Manufacturing Co., Ltd. | 05/10/2010SE |
| K100315 | 12 Lead GloveDRX · Special | I Needmd, Inc. | 04/23/2010SE |
| K092744 | Neonatal ECG Electrode, M203KENDRX · Traditional | R & D Medical Products, Inc. | 12/10/2009SE |
| K092389 | Disposal ECG Electrodes, Model EasyrodeDRX · Traditional | Suzuken Co., Ltd. | 10/13/2009SE |
More from Suzuken Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K030073 | Vermed A10021 Resting EKG Tab ElectrodeDRX · Special | 03/28/2003SE |
| K021537 | Multipurpose Neuroplus Electrode, Model A10005GXY · Traditional | 03/03/2003SE |
| K010638 | Neuroplus, Model A10040, A10041, A10042, A10043GXY · Traditional | 05/03/2001SE |
| K921498 | Ver Med A10011 PNS Dual Element ElectrodeBXM · Traditional | 06/09/1993SE |
| K915831 | Thermal Probe CoverFMT · Traditional | 06/08/1992SE |
| K911687 | Ver-Med A10020 Resting EKG ElectrodeDRX · Traditional | 10/10/1991SE |
| K910139 | Ver-Med A10014 Resting EKG Electrode & A10021DRX · Traditional | 08/15/1991SE |
| K781430 | Pregelled Disposable E.K.G. ElectrodeDRX · Traditional | 10/31/1978SE |
Questions and answers
When was Ver-Med A10017 Universal Electrode cleared by the FDA?
Ver-Med A10017 Universal Electrode (K905489) received a 510(k) decision of Substantially Equivalent on March 21, 1991, 104 days after the submission was received.
What is the product code of K905489?
The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.