CLEARVIEW TOTAL— 510(k) K131781
Substantially EquivalentClinical Innovations, LLC
FDA 510(k) clearance K131781 for CLEARVIEW TOTAL, Substantially Equivalent on 2014-05-28. Applicant: Clinical Innovations, LLC. Device class: 2.
Clearance details
- Applicant
- Clinical Innovations, LLC
- Product code
- Code LKF
- Device class
- Class 2
- Regulation
- 21 CFR 884.4530
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Murray, UT, US
Recent devices under product code LKF
view allMore clearances from Clinical Innovations, LLC
view allAdverse events under product code LKF
product code LKF- Malfunction
- 643
- Other
- 2
- Total
- 645
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 K131781
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 K131781.
Data sourced from openFDA. This site is unofficial and independent of the FDA.