Care Disp. Diag. Electrodes, Silver/Silver
FDA 510(k) K894462 · Labeltape Meditect, Inc.
510(k) numberK894462
Submission
- Device name
- Care Disp. Diag. Electrodes, Silver/Silver
- Applicant
- Labeltape Meditect, Inc.
Grand Rapids, MI, US - Received
- July 18, 1989
- Decision date
- October 12, 1989
- 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
Other 510(k)s with product code DRX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K171244 | PhysiotraceDRX · Traditional | Nimbleheart, Inc. | 08/23/2017SE |
| K140096 | Hmicro Wired C-Patch Electrode, Trade Name Subject to ChangeDRX · Traditional | Hmicro, Inc. | 07/24/2014SE |
| K123658 | Biomodule 3-M1DRX · Traditional | Zephyr Technology Corporation | 04/24/2013SE |
| K101576 | Centerridge Diagnostic ECG Electrode, Centerridge Monitoring ECG ElectrodesDRX · Traditional | Team Innovations, Inc. | 07/22/2010SE |
| K101685 | Ip-SetDRX · Traditional | Integral Process Sas | 07/01/2010SE |
| 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 |
|---|---|---|
| K951328 | Lmi Medical, Electrode, Electrosurgical, Disposable Dispersive Electrode with CordGEI · Traditional | 04/25/1995SE |
| K915333 | Electrode Using Promeon RG-60 Series GelGXY · Traditional | 01/14/1992SE |
| K914871 | Trans Elec Nerve Stim/Muscle Stim Elec W/Poly GelGZJ · Traditional | 12/18/1991SE |
| K912979 | Hemawipe System, the Civilized Test, ModificationKHE · Traditional | 10/04/1991SE |
| K902738 | Electro Blue ECG Electrode-Pediatric ClothDRX · Traditional | 09/04/1990SE |
| K902719 | Spect.E.N.S. Repostion.-E Foam Pin Type TENS ElectGXY · Traditional | 07/19/1990SE |
| K900656 | Spec T.E.N.S. Prewired Repositionable TENS Elect.GXY · Traditional | 03/01/1990SE |
| K896844 | Babe-Ease Neonatal Cloth ECG ElectrodeGXY · Traditional | 02/12/1990SE |
| K896936 | L.A.S.P. Lumbar and Sacral Pad, Reposition. SnapGXY · Traditional | 01/22/1990SE |
| K894991 | Electro Blue ECG Elect. Foam, Silver/Silver Chlo.DRX · Traditional | 10/26/1989SE |
Questions and answers
When was Care Disp. Diag. Electrodes, Silver/Silver cleared by the FDA?
Care Disp. Diag. Electrodes, Silver/Silver (K894462) received a 510(k) decision of Substantially Equivalent on October 12, 1989, 86 days after the submission was received.
What is the product code of K894462?
The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.