The Belmont Hyperthermia Pump— 510(k) K152208

Substantially Equivalent

Belmont Instrument Corporation

FDA 510(k) clearance K152208 for The Belmont Hyperthermia Pump, Substantially Equivalent on 2015-09-02. Applicant: Belmont Instrument Corporation.

Clearance details

Applicant: Belmont Instrument Corporation
Product code: Code LGZ
Advisory panel: General Hospital
Date received: 2015-08-07
Decision date: 2015-09-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Billerica, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LGZ

product code LGZ

Death: 16
Malfunction: 5,916
Other: 1
Total: 5,933

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.