FDA 510(k)

decimal Bolus

K-Number: K211511 · 2021-07-01

Decision Date2021-07-01

Product CodeMUJ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

decimal Bolus is the device name listed in this FDA 510(k) record. The listed applicant is .Decimal, LLC. It received FDA 510(k) clearance on 2021-07-01 under 510(k) 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. The listed applicant is .Decimal, LLC. The 510(k) number is K211511.

When did decimal Bolus receive FDA 510(k) clearance?

decimal Bolus received FDA 510(k) clearance on 2021-07-01, under 510(k) number K211511.

Who is the listed applicant for decimal Bolus?

The FDA 510(k) record lists .Decimal, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for decimal Bolus?

The FDA product code for decimal Bolus is MUJ.

Other records listing .Decimal, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.