decimal Bolus
K-Number: K211511 · 2021-07-01
Applicant.Decimal, LLC
Decision Date2021-07-01
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
decimal Bolus is a medical device manufactured by .Decimal, LLC. It received FDA 510(k) clearance on 2021-07-01 under approval number K211511. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the decimal Bolus?
decimal Bolus is a medical device that received FDA 510(k) clearance on 2021-07-01. It is manufactured by .Decimal, LLC. The 510(k) number is K211511.
When was decimal Bolus approved by the FDA?
decimal Bolus received FDA 510(k) clearance on 2021-07-01, under approval number K211511.
What company makes decimal Bolus?
decimal Bolus is manufactured by .Decimal, LLC.
What is the FDA product code for decimal Bolus?
The FDA product code for decimal Bolus is MUJ.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.