AMEDA AMELETTE(R) NEONATAL INCUBATOR— 510(k) K870223

Substantially Equivalent

Hollister, Inc.

FDA 510(k) clearance K870223 for AMEDA AMELETTE(R) NEONATAL INCUBATOR, Substantially Equivalent on 1987-06-10. Applicant: Hollister, Inc..

Clearance details

Applicant: Hollister, Inc.
Product code: Code FMZ
Advisory panel: General Hospital
Date received: 1987-01-21
Decision date: 1987-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

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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.