decimal Bolus— 510(k) K211511
Substantially Equivalent.Decimal, LLC
FDA 510(k) clearance K211511 for decimal Bolus, Substantially Equivalent on 2021-07-01. Applicant: .Decimal, LLC. Device class: 2.
Clearance details
- Applicant
- .Decimal, LLC
- Product code
- Product code MUJ
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sanford, FL, US
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