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FDA 510(k)

CleaniCal

K-Number: K201799 · 2021-02-12

ApplicantMaruchi
Decision Date2021-02-12
Product CodeEJK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CleaniCal is a medical device manufactured by Maruchi. It received FDA 510(k) clearance on 2021-02-12 under approval number K201799. The device is classified under product code EJK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CleaniCal?

CleaniCal is a medical device that received FDA 510(k) clearance on 2021-02-12. It is manufactured by Maruchi. The 510(k) number is K201799.

When was CleaniCal approved by the FDA?

CleaniCal received FDA 510(k) clearance on 2021-02-12, under approval number K201799.

What company makes CleaniCal?

CleaniCal is manufactured by Maruchi.

What is the FDA product code for CleaniCal?

The FDA product code for CleaniCal is EJK.

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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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