TCX-I REMOTE CARE MANAGEMENT SYSTEM— 510(k) K113493

Substantially Equivalent

Bl Healthcare, Inc.

FDA 510(k) clearance K113493 for TCX-I REMOTE CARE MANAGEMENT SYSTEM, Substantially Equivalent on 2011-12-21. Applicant: Bl Healthcare, Inc..

Clearance details

Applicant: Bl Healthcare, Inc.
Product code: Code DRG
Advisory panel: Cardiovascular
Date received: 2011-11-25
Decision date: 2011-12-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Foxboro, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRG

product code DRG

Death: 5
Total: 5

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.