INCUBATOR 8000— 510(k) K900752

Substantially Equivalent

Dragerwerk AG

FDA 510(k) clearance K900752 for INCUBATOR 8000, Substantially Equivalent on 1990-08-02. Applicant: Dragerwerk AG.

Clearance details

Applicant: Dragerwerk AG
Product code: Code FMZ
Advisory panel: General Hospital
Date received: 1990-02-16
Decision date: 1990-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pittsburgh, PA, 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.