AMBIO REMOTE HEALTH MONITORING SYSTEM— 510(k) K130676
Substantially EquivalentArrayent Health, LLC D/B/A Ambio Health
FDA 510(k) clearance K130676 for AMBIO REMOTE HEALTH MONITORING SYSTEM, Substantially Equivalent on 2013-07-08. Applicant: Arrayent Health, LLC D/B/A Ambio Health.
Clearance details
- Applicant
- Arrayent Health, LLC D/B/A Ambio Health
- Product code
- Code DRG
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Stamford, CT, US
Adverse 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.