OHIO GC INCUBATOR— 510(k) K802640

Substantially Equivalent

Ohio Medical Products

FDA 510(k) clearance K802640 for OHIO GC INCUBATOR, Substantially Equivalent on 1980-11-12. Applicant: Ohio Medical Products.

Clearance details

Applicant: Ohio Medical Products
Product code: Code FMZ
Advisory panel: General Hospital
Date received: 1980-10-23
Decision date: 1980-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.