FDA 510(k)

CRUXVIEW

K-Number: K211317 · 2021-07-29

Decision Date2021-07-29

Product CodeMUH

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

CRUXVIEW is the device name listed in this FDA 510(k) record. The listed applicant is Cruxell Corp.. It received FDA 510(k) clearance on 2021-07-29 under 510(k) number K211317. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRUXVIEW?

CRUXVIEW is a medical device that received FDA 510(k) clearance on 2021-07-29. The listed applicant is Cruxell Corp.. The 510(k) number is K211317.

When did CRUXVIEW receive FDA 510(k) clearance?

CRUXVIEW received FDA 510(k) clearance on 2021-07-29, under 510(k) number K211317.

Who is the listed applicant for CRUXVIEW?

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

What is the FDA product code for CRUXVIEW?

The FDA product code for CRUXVIEW is MUH.

Other records listing Cruxell Corp. 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.

K183637Cruxcan (CRX-1000)

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Official Source

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