V-505 INFA WARMER— 510(k) K060461

Substantially Equivalent

Atom Medical, Inc.

FDA 510(k) clearance K060461 for V-505 INFA WARMER, Substantially Equivalent on 2006-04-28. Applicant: Atom Medical, Inc..

Clearance details

Applicant: Atom Medical, Inc.
Product code: Code FMT
Advisory panel: General Hospital
Date received: 2006-02-22
Decision date: 2006-04-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Tokoyo, Bunkyo-Ku, 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.