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FDA 510(k)

FS Ergo

K-Number: K173646 · 2017-12-19

ApplicantPalodex Group OY
Decision Date2017-12-19
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FS Ergo is the device name listed in this FDA 510(k) record. The listed applicant is Palodex Group OY. It received FDA 510(k) clearance on 2017-12-19 under 510(k) number K173646. 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 FS Ergo?

FS Ergo is a medical device that received FDA 510(k) clearance on 2017-12-19. The listed applicant is Palodex Group OY. The 510(k) number is K173646.

When did FS Ergo receive FDA 510(k) clearance?

FS Ergo received FDA 510(k) clearance on 2017-12-19, under 510(k) number K173646.

Who is the listed applicant for FS Ergo?

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

What is the FDA product code for FS Ergo?

The FDA product code for FS Ergo is MUH.

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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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