AnemoCheck— 510(k) K163215
Substantially EquivalentSanguina, LLC
FDA 510(k) clearance K163215 for AnemoCheck, Substantially Equivalent on 2017-09-13. Applicant: Sanguina, LLC. Device class: 2.
Clearance details
- Applicant
- Sanguina, LLC
- Product code
- Code KHG
- Device class
- Class 2
- Regulation
- 21 CFR 864.7500
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Atlanta, GA, US
Recent devices under product code KHG
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