OHMEDA HEAT REFLECTING PATCH— 510(k) K853351

Substantially Equivalent

Ohmeda Medical

FDA 510(k) clearance K853351 for OHMEDA HEAT REFLECTING PATCH, Substantially Equivalent on 1985-10-17. Applicant: Ohmeda Medical.

Clearance details

Applicant: Ohmeda Medical
Product code: Code FMT
Advisory panel: General Hospital
Date received: 1985-08-12
Decision date: 1985-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Madison, WI, 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.