FLUTTER D— 510(k) K972859

Name: FDA 510(k) clearance K972859
Creator: U.S. Food and Drug Administration
Published: 1998-06-05

Substantially Equivalent

Bradstreet Clinical Research Assoc., Inc.

FDA 510(k) clearance K972859 for FLUTTER D, Substantially Equivalent on 1998-06-05. Applicant: Bradstreet Clinical Research Assoc., Inc.. Device class: 2.

Clearance details

Applicant: Bradstreet Clinical Research Assoc., Inc.
Product code: Code BYI
Device class: Class 2
Regulation: 21 CFR 868.5665
Advisory panel: Anesthesiology
Date received: 1997-08-04
Decision date: 1998-06-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brunswick, NJ, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code BYI

product code BYI

Death: 3
Total: 3

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.