Portable ECG Monitor (ECG3)— 510(k) K172862
Substantially EquivalentAndon Health Co, Ltd.
FDA 510(k) clearance K172862 for Portable ECG Monitor (ECG3), Substantially Equivalent on 2018-07-24. Applicant: Andon Health Co, Ltd.. Device class: 2.
Clearance details
- Applicant
- Andon Health Co, Ltd.
- Product code
- Code DSH
- Device class
- Class 2
- Regulation
- 21 CFR 870.2800
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tianjin, CN
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Adverse events under product code DSH
product code DSH- Death
- 3
- Injury
- 652
- Total
- 655
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.