NEOCARE MODEL 800 INFANT RADIANT WARMER— 510(k) K853926

Name: FDA 510(k) clearance K853926
Creator: U.S. Food and Drug Administration
Published: 1986-02-26

Substantially Equivalent

Draeger Medical, Inc.

FDA 510(k) clearance K853926 for NEOCARE MODEL 800 INFANT RADIANT WARMER, Substantially Equivalent on 1986-02-26. Applicant: Draeger Medical, Inc.. Device class: 2.

Clearance details

Applicant: Draeger Medical, Inc.
Product code: Code FMT
Device class: Class 2
Regulation: 21 CFR 880.5130
Advisory panel: General Hospital
Date received: 1985-09-24
Decision date: 1986-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Telford, PA, 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.