INCU I— 510(k) K102279

Substantially Equivalent

Atom Medical Corporation

FDA 510(k) clearance K102279 for INCU I, Substantially Equivalent on 2010-12-29. Applicant: Atom Medical Corporation.

Clearance details

Applicant: Atom Medical Corporation
Product code: Code FMZ
Advisory panel: General Hospital
Date received: 2010-08-11
Decision date: 2010-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bunkyo-Ku, Tokyo, JP

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.