NuBorne Infant Warmer— 510(k) K173516

Clearance details

Applicant

International Biomedical

Product code

Code FMT

Device class

Class 2

Regulation

21 CFR 880.5130

Advisory panel

General Hospital

Date received

2017-11-14

Decision date

2018-08-17

Decision

Substantially Equivalent

Clearance type

Abbreviated

Location

Austin, TX, US

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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 →