ScioCardio ECG Transmitter
FDA 510(k) K171019 · Synergen Technology Labs, LLC
510(k) numberK171019
Submission
- Device name
- ScioCardio ECG Transmitter
- Applicant
- Synergen Technology Labs, LLC
Dallas, TX, US - Received
- April 5, 2017
- Decision date
- May 30, 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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More from Cardioline S.P.A
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|---|---|---|
| K252978 | ScioCardio ECG Analysis PlatformDQK · Traditional | 07/09/2026SE |
Questions and answers
When was ScioCardio ECG Transmitter cleared by the FDA?
ScioCardio ECG Transmitter (K171019) received a 510(k) decision of Substantially Equivalent on May 30, 2018, 420 days after the submission was received.
What is the product code of K171019?
The FDA product code is DRG – Transmitters And Receivers, Physiological Signal, Radiofrequency, a Class II (moderate risk) device regulated under 21 CFR 870.2910.