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FDA 510(k)

STELLA BIO

K-Number: K210002 · 2021-10-01

ApplicantEgzotech Sp. Z O. O.
Decision Date2021-10-01
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

STELLA BIO is a medical device manufactured by Egzotech Sp. Z O. O.. It received FDA 510(k) clearance on 2021-10-01 under approval number K210002. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STELLA BIO?

STELLA BIO is a medical device that received FDA 510(k) clearance on 2021-10-01. It is manufactured by Egzotech Sp. Z O. O.. The 510(k) number is K210002.

When was STELLA BIO approved by the FDA?

STELLA BIO received FDA 510(k) clearance on 2021-10-01, under approval number K210002.

What company makes STELLA BIO?

STELLA BIO is manufactured by Egzotech Sp. Z O. O..

What is the FDA product code for STELLA BIO?

The FDA product code for STELLA BIO is IPF.

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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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