FDA 510(k)

CleaniCal

K-Number: K201799 · 2021-02-12

Decision Date2021-02-12

Product CodeEJK

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

CleaniCal is the device name listed in this FDA 510(k) record. The listed applicant is Maruchi. It received FDA 510(k) clearance on 2021-02-12 under 510(k) 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. The listed applicant is Maruchi. The 510(k) number is K201799.

When did CleaniCal receive FDA 510(k) clearance?

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

Who is the listed applicant for CleaniCal?

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

What is the FDA product code for CleaniCal?

The FDA product code for CleaniCal is EJK.

Other records listing Maruchi 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.