HOTLINE 2 FLUID WARMER— 510(k) K001764

Substantially Equivalent

Sims Level 1, Inc.

FDA 510(k) clearance K001764 for HOTLINE 2 FLUID WARMER, Substantially Equivalent on 2000-08-09. Applicant: Sims Level 1, Inc..

Clearance details

Applicant: Sims Level 1, Inc.
Product code: Code LGZ
Advisory panel: General Hospital
Date received: 2000-06-12
Decision date: 2000-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockland, 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.