B-SMART, MODEL B-01— 510(k) K031128

Name: FDA 510(k) clearance K031128
Creator: U.S. Food and Drug Administration
Published: 2004-01-15

Substantially Equivalent

Macosta Medical USA, LLC

FDA 510(k) clearance K031128 for B-SMART, MODEL B-01, Substantially Equivalent on 2004-01-15. Applicant: Macosta Medical USA, LLC. Device class: 2.

Clearance details

Applicant: Macosta Medical USA, LLC
Product code: Code CAZ
Device class: Class 2
Regulation: 21 CFR 868.5140
Advisory panel: Anesthesiology
Date received: 2003-04-09
Decision date: 2004-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ayer, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code CAZ

product code CAZ

Injury: 145
Malfunction: 942
Other: 1
Total: 1,088

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.