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FDA 510(k)

e-Motion M25

K-Number: K192618 · 2020-11-02

ApplicantAlber GmbH
Decision Date2020-11-02
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

e-Motion M25 is the device name listed in this FDA 510(k) record. The listed applicant is Alber GmbH. It received FDA 510(k) clearance on 2020-11-02 under 510(k) number K192618. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the e-Motion M25?

e-Motion M25 is a medical device that received FDA 510(k) clearance on 2020-11-02. The listed applicant is Alber GmbH. The 510(k) number is K192618.

When did e-Motion M25 receive FDA 510(k) clearance?

e-Motion M25 received FDA 510(k) clearance on 2020-11-02, under 510(k) number K192618.

Who is the listed applicant for e-Motion M25?

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

What is the FDA product code for e-Motion M25?

The FDA product code for e-Motion M25 is ITI.

Other records listing Alber GmbH 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.

K221215e-motion M25K192016SMOOV O10K161241e-fix E35/E36K151717twion

Related Devices (Code: ITI)

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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.

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