ScioCardio ECG Transmitter— 510(k) K171019
Substantially EquivalentSynergen Technology Labs, LLC
FDA 510(k) clearance K171019 for ScioCardio ECG Transmitter, Substantially Equivalent on 2018-05-30. Applicant: Synergen Technology Labs, LLC. Device class: 2.
Clearance details
- Applicant
- Synergen Technology Labs, LLC
- Product code
- Code DRG
- Device class
- Class 2
- Regulation
- 21 CFR 870.2910
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dallas, TX, US
Recent devices under product code DRG
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view allAdverse events under product code DRG
product code DRG- Death
- 5
- Total
- 5
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.