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FDA 510(k)

Capsulo

K-Number: K220430 · 2022-05-12

ApplicantQuantel Medical
Decision Date2022-05-12
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Capsulo is a medical device manufactured by Quantel Medical. It received FDA 510(k) clearance on 2022-05-12 under approval number K220430. The device is classified under product code HQF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Capsulo?

Capsulo is a medical device that received FDA 510(k) clearance on 2022-05-12. It is manufactured by Quantel Medical. The 510(k) number is K220430.

When was Capsulo approved by the FDA?

Capsulo received FDA 510(k) clearance on 2022-05-12, under approval number K220430.

What company makes Capsulo?

Capsulo is manufactured by Quantel Medical.

What is the FDA product code for Capsulo?

The FDA product code for Capsulo is HQF.

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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.

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