INFANT INCUBATOR— 510(k) K132543

Substantially Equivalent

Bistos Co., Ltd.

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

Clearance details

Applicant: Bistos Co., Ltd.
Product code: Code FMZ
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 ↗

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.