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

Name: FDA 510(k) clearance K052608
Creator: U.S. Food and Drug Administration
Published: 2006-02-01

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.. Device class: 2.

Clearance details

Applicant: Bl Healthcare, Inc.
Product code: Code DRG
Device class: Class 2
Regulation: 21 CFR 870.2910
Advisory panel: Cardiovascular
Date received: 2005-09-22
Decision date: 2006-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Foxboro, MA, US

Download summary PDF View on FDA.gov ↗

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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.