K901157

Substantially Equivalent

MP4, MP4SI, IT4 INCUBATORS

Applicant: Mediprema
Product code: FMZ
Advisory panel: General Hospital
Date received: 1990-03-13
Decision date: 1991-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sandpoint, ID, US

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.