INFUSION FLUID WARMER— 510(k) K883873

Name: FDA 510(k) clearance K883873
Creator: U.S. Food and Drug Administration
Published: 1989-02-28

Substantially Equivalent

Pmt Corp.

FDA 510(k) clearance K883873 for INFUSION FLUID WARMER, Substantially Equivalent on 1989-02-28. Applicant: Pmt Corp.. Device class: 2.

Clearance details

Applicant: Pmt Corp.
Product code: Code LGZ
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 1988-09-13
Decision date: 1989-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chanhassen, MN, US

Download summary PDF View on FDA.gov ↗

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K042901 — ENDOMARK STERILE INDIA INK2005-03-16
K033730 — PMT SPHENOIDAL ELECTRODE AND ACCESSORY, MODEL 2101-31 AND 2102-31 SERIES2004-08-03

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.