ARUBI FLATTER & ARUBI FLATTER-S— 510(k) K831206
Substantially EquivalentKc Export Management Co.
FDA 510(k) clearance K831206 for ARUBI FLATTER & ARUBI FLATTER-S, Substantially Equivalent on 1983-06-02. Applicant: Kc Export Management Co.. Device class: 1.
Clearance details
- Applicant
- Kc Export Management Co.
- Product code
- Code ISA
- Device class
- Class 1
- Regulation
- 21 CFR 890.5660
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code ISA
view allAdverse events under product code ISA
product code ISA- Death
- 3
- Other
- 1
- Total
- 4
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.