Pregelled Infant Disposable ECG Electrode
FDA 510(k) K862756 · Labeltape Meditect, Inc.
510(k) numberK862756
Submission
- Device name
- Pregelled Infant Disposable ECG Electrode
- Applicant
- Labeltape Meditect, Inc.
Grand Rapids, MI, US - Received
- July 22, 1986
- Decision date
- August 6, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXN – System, Measurement, Blood-Pressure, Non-Invasive
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1130
- Specialty
- Cardiovascular
Other 510(k)s with product code DXN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261929 | Upper Arm Blood pressure monitor (BP7155D)DXN · Special | OMRON Healthcare, Inc. | 09/10/2026SE |
| K254000 | Happy Health Blood Pressure MonitorDXN · Traditional | Happy Health, Inc. | 09/03/2026SE |
| K262658 | Automatic Digital Blood Pressure monitor (LD-526)DXN · Special | Honsun (Nantong) Co., Ltd. | 08/31/2026SE |
| K261394 | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus…DXN · Traditional | JOYTECH Healthcare Co., Ltd. | 08/26/2026SE |
| K261061 | BP Go (BPP-855)DXN · Traditional | Wellvii, Inc. | 08/13/2026SE |
| K253425 | Arm-type Fully Automatic Digital Blood Pressure Monitor…DXN · Traditional | Joytech Healthcare Co. , Ltd. | 08/13/2026SE |
| K261136 | Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)DXN · Traditional | Guangzhou Daxin Health Technology Co., Ltd. | 07/23/2026SE |
| K261082 | Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)DXN · Traditional | Microlife Corporation | 07/23/2026SE |
| K253126 | Wrist Blood Pressure Monitor (XW-05)DXN · Traditional | Shenzhen Ziqing Medical Equipment Co., Ltd. | 06/18/2026SE |
| K260693 | VicorderCS (VCS-SYS-1100)DXN · Traditional | 80 Beats Medical GmbH | 06/16/2026SE |
More from 80 Beats Medical GmbH
| 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 Pregelled Infant Disposable ECG Electrode cleared by the FDA?
Pregelled Infant Disposable ECG Electrode (K862756) received a 510(k) decision of Substantially Equivalent on August 6, 1986, 15 days after the submission was received.
What is the product code of K862756?
The FDA product code is DXN – System, Measurement, Blood-Pressure, Non-Invasive, a Class II (moderate risk) device regulated under 21 CFR 870.1130.