THE BELMONT BUDDY LITE FLUID WARMER— 510(k) K112639

Substantially Equivalent

Belmont Instrument Corp.

FDA 510(k) clearance K112639 for THE BELMONT BUDDY LITE FLUID WARMER, Substantially Equivalent on 2011-11-16. Applicant: Belmont Instrument Corp..

Clearance details

Applicant: Belmont Instrument Corp.
Product code: Code BSB
Advisory panel: Hematology
Date received: 2011-09-12
Decision date: 2011-11-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Billerica, MA, US

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Adverse events under product code BSB

product code BSB

Death: 5
Malfunction: 1,778
Total: 1,783

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.