OHIO 3300 INFANT WARMER SYSTEM— 510(k) K840858

Substantially Equivalent

Ohio Medical Products

FDA 510(k) clearance K840858 for OHIO 3300 INFANT WARMER SYSTEM, Substantially Equivalent on 1984-03-23. Applicant: Ohio Medical Products.

Clearance details

Applicant: Ohio Medical Products
Product code: Code FMT
Advisory panel: General Hospital
Date received: 1984-02-24
Decision date: 1984-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FMT

product code FMT

Death: 4
Malfunction: 3,074
Total: 3,078

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.