PATIENT WARMER MODEL 100C— 510(k) K910915

Name: FDA 510(k) clearance K910915
Creator: U.S. Food and Drug Administration
Published: 1991-07-16

Substantially Equivalent

Developmed Corp.

FDA 510(k) clearance K910915 for PATIENT WARMER MODEL 100C, Substantially Equivalent on 1991-07-16. Applicant: Developmed Corp.. Device class: 2.

Clearance details

Applicant: Developmed Corp.
Product code: Code FMT
Device class: Class 2
Regulation: 21 CFR 880.5130
Advisory panel: General Hospital
Date received: 1991-03-05
Decision date: 1991-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FMT

product code FMT

Death: 4
Malfunction: 3,074
Total: 3,078

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.