FDA 510(k)

STELLA BIO

K-Number: K210002 · 2021-10-01

Decision Date2021-10-01

Product CodeIPF

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

STELLA BIO is the device name listed in this FDA 510(k) record. The listed applicant is Egzotech Sp. Z O. O.. It received FDA 510(k) clearance on 2021-10-01 under 510(k) 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. The listed applicant is Egzotech Sp. Z O. O.. The 510(k) number is K210002.

When did STELLA BIO receive FDA 510(k) clearance?

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

Who is the listed applicant for STELLA BIO?

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

What is the FDA product code for STELLA BIO?

The FDA product code for STELLA BIO is IPF.

Related Devices (Code: IPF)

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.

K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.K252816High Tone Power therapy (HiToP) (Model: HiToP PNP)Mohammadali Nezakati K260142StimelMD (SSMD) systemMotion Informatics ltd.K251083Compact IIEnraf-Nonius, B.V.K241433EVE Synergy (EVE-20M)Weero Co., Ltd.K241488TrainFES AdvanceTrainfes

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.