K113493
Substantially EquivalentTCX-I REMOTE CARE MANAGEMENT SYSTEM
- Applicant
- Bl Healthcare, Inc.
- Product code
- DRG
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Foxboro, MA, 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.