INFANT INCUBATOR— 510(k) K132543

Name: FDA 510(k) clearance K132543
Creator: U.S. Food and Drug Administration
Published: 2014-07-03

Substantially Equivalent

Bistos Co., Ltd.

FDA 510(k) clearance K132543 for INFANT INCUBATOR, Substantially Equivalent on 2014-07-03. Applicant: Bistos Co., Ltd.. Device class: 2.

Clearance details

Applicant: Bistos Co., Ltd.
Product code: Code FMZ
Device class: Class 2
Regulation: 21 CFR 880.5400
Advisory panel: General Hospital
Date received: 2013-08-13
Decision date: 2014-07-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ramsey, NJ, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FMZ

product code FMZ

Death: 2
Malfunction: 457
Other: 1
Total: 460

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.