Hmicro Wired C-Patch Electrode, Trade Name Subject to Change
FDA 510(k) K140096 · Hmicro, Inc.
510(k) numberK140096
Submission
- Device name
- Hmicro Wired C-Patch Electrode, Trade Name Subject to Change
- Applicant
- Hmicro, Inc.
Los Altos, CA, US - Received
- January 14, 2014
- Decision date
- July 24, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRX – Electrode, Electrocardiograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2360
- Specialty
- Cardiovascular
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| 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 |
| K090496 | Qwiklead Reusable Electrocardiograph Electrode PatchDRX · Traditional | Cardiac Lead Technologies, Inc. | 09/01/2009SE |
More from Cardiac Lead Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K172011 | LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System)DRG · Traditional | 06/14/2018SE |
Questions and answers
When was Hmicro Wired C-Patch Electrode, Trade Name Subject to Change cleared by the FDA?
Hmicro Wired C-Patch Electrode, Trade Name Subject to Change (K140096) received a 510(k) decision of Substantially Equivalent on July 24, 2014, 191 days after the submission was received.
What is the product code of K140096?
The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.