AMERICAN BANTEX MS 4 MINI SCOOTER— 510(k) K040754
Substantially EquivalentAmerican Bantex Corp.
FDA 510(k) clearance K040754 for AMERICAN BANTEX MS 4 MINI SCOOTER, Substantially Equivalent on 2004-07-23. Applicant: American Bantex Corp.. Device class: 2.
Clearance details
- Applicant
- American Bantex Corp.
- Product code
- Code INI
- Device class
- Class 2
- Regulation
- 21 CFR 890.3800
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bountiful, UT, US
Recent devices under product code INI
view allMore clearances from American Bantex Corp.
view allAdverse events under product code INI
product code INI- Injury
- 171
- Other
- 1
- Total
- 172
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.