MINISCAV— 510(k) K160950
Substantially EquivalentSedation Systems, LLC
FDA 510(k) clearance K160950 for MINISCAV, Substantially Equivalent on 2017-05-05. Applicant: Sedation Systems, LLC. Device class: 2.
Clearance details
- Applicant
- Sedation Systems, LLC
- Product code
- Code CBN
- Device class
- Class 2
- Regulation
- 21 CFR 868.5430
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Clearwater, FL, US
Recent devices under product code CBN
view allRecalls naming K160950
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 K160950.
Data sourced from openFDA. This site is unofficial and independent of the FDA.