COMPACT FOUR— 510(k) K831896
Substantially EquivalentNicolet Biomedical Instruments
FDA 510(k) clearance K831896 for COMPACT FOUR, Substantially Equivalent on 1983-07-28. Applicant: Nicolet Biomedical Instruments. Device class: 2.
Clearance details
- Applicant
- Nicolet Biomedical Instruments
- Product code
- Code GWF
- Device class
- Class 2
- Regulation
- 21 CFR 882.1870
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
Recent devices under product code GWF
view allMore clearances from Nicolet Biomedical Instruments
view allAdverse events under product code GWF
product code GWF- Malfunction
- 2,364
- Other
- 4
- Total
- 2,368
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.