TELEPHONE BASED BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM (RCMS)— 510(k) K052608

Substantially Equivalent

Bl Healthcare, Inc.

FDA 510(k) clearance K052608 for TELEPHONE BASED BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM (RCMS), Substantially Equivalent on 2006-02-01. Applicant: Bl Healthcare, Inc..

Clearance details

Applicant: Bl Healthcare, Inc.
Product code: Code DRG
Advisory panel: Cardiovascular
Date received: 2005-09-22
Decision date: 2006-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Foxboro, MA, US

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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.