INFA WARMER I— 510(k) K102227

Substantially Equivalent

Atom Medical Corporation

FDA 510(k) clearance K102227 for INFA WARMER I, Substantially Equivalent on 2011-01-21. Applicant: Atom Medical Corporation.

Clearance details

Applicant: Atom Medical Corporation
Product code: Code FMT
Advisory panel: General Hospital
Date received: 2010-08-09
Decision date: 2011-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bunkyo-Ku, Tokyo, JP

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.