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FDA 510(k)

e-fix E35/E36

K-Number: K161241 · 2016-10-05

ApplicantAlber GmbH
Decision Date2016-10-05
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

e-fix E35/E36 is the device name listed in this FDA 510(k) record. The listed applicant is Alber GmbH. It received FDA 510(k) clearance on 2016-10-05 under 510(k) number K161241. 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-fix E35/E36?

e-fix E35/E36 is a medical device that received FDA 510(k) clearance on 2016-10-05. The listed applicant is Alber GmbH. The 510(k) number is K161241.

When did e-fix E35/E36 receive FDA 510(k) clearance?

e-fix E35/E36 received FDA 510(k) clearance on 2016-10-05, under 510(k) number K161241.

Who is the listed applicant for e-fix E35/E36?

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-fix E35/E36?

The FDA product code for e-fix E35/E36 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 M25K192618e-Motion M25K192016SMOOV O10K151717twion

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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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