FDA 510(k)

StimaWELL 120MTRS

K-Number: K181645 · 2020-08-13

Decision Date2020-08-13

Product CodeGZJ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

StimaWELL 120MTRS is the device name listed in this FDA 510(k) record. The listed applicant is Pierenkemper GmbH. It received FDA 510(k) clearance on 2020-08-13 under 510(k) number K181645. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the StimaWELL 120MTRS?

StimaWELL 120MTRS is a medical device that received FDA 510(k) clearance on 2020-08-13. The listed applicant is Pierenkemper GmbH. The 510(k) number is K181645.

When did StimaWELL 120MTRS receive FDA 510(k) clearance?

StimaWELL 120MTRS received FDA 510(k) clearance on 2020-08-13, under 510(k) number K181645.

Who is the listed applicant for StimaWELL 120MTRS?

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

What is the FDA product code for StimaWELL 120MTRS?

The FDA product code for StimaWELL 120MTRS is GZJ.

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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.