LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System)
FDA 510(k) K172011 · Hmicro, Inc.
510(k) numberK172011
Submission
- Device name
- LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System)
- Applicant
- Hmicro, Inc.
Fremont, CA, US - Received
- July 3, 2017
- Decision date
- June 14, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRG – Transmitters And Receivers, Physiological Signal, Radiofrequency
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2910
- Specialty
- Cardiovascular
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| K241101 | BioButton SystemDRG · Traditional | Biointellisense, Inc. | 09/26/2024SE |
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More from Cardioline S.P.A
| 510(k) | Device | Decision |
|---|---|---|
| K140096 | Hmicro Wired C-Patch Electrode, Trade Name Subject to ChangeDRX · Traditional | 07/24/2014SE |
Questions and answers
When was LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System) cleared by the FDA?
LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System) (K172011) received a 510(k) decision of Substantially Equivalent on June 14, 2018, 346 days after the submission was received.
What is the product code of K172011?
The FDA product code is DRG – Transmitters And Receivers, Physiological Signal, Radiofrequency, a Class II (moderate risk) device regulated under 21 CFR 870.2910.