DUAL INCU I— 510(k) K102226
Substantially EquivalentAtom Medical Corporation
FDA 510(k) clearance K102226 for DUAL INCU I, Substantially Equivalent on 2011-01-04. Applicant: Atom Medical Corporation. Device class: 2.
Clearance details
- Applicant
- Atom Medical Corporation
- Product code
- Code FMZ
- Device class
- Class 2
- Regulation
- 21 CFR 880.5400
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bunkyo-Ku, Tokyo, JP
Recent devices under product code FMZ
view allMore clearances from Atom Medical Corporation
view allAdverse events under product code FMZ
product code FMZ- Death
- 2
- Malfunction
- 457
- Other
- 1
- Total
- 460
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K102226
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K102226.
Data sourced from openFDA. This site is unofficial and independent of the FDA.