FDA 510(k)

JETT PLASMA Medical II

K-Number: K213247 · 2023-03-14

Decision Date2023-03-14

Product CodeQVJ

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

JETT PLASMA Medical II is the device name listed in this FDA 510(k) record. The listed applicant is Compex, Spol, S.R.O.. It received FDA 510(k) clearance on 2023-03-14 under 510(k) number K213247. The device is classified under product code QVJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JETT PLASMA Medical II?

JETT PLASMA Medical II is a medical device that received FDA 510(k) clearance on 2023-03-14. The listed applicant is Compex, Spol, S.R.O.. The 510(k) number is K213247.

When did JETT PLASMA Medical II receive FDA 510(k) clearance?

JETT PLASMA Medical II received FDA 510(k) clearance on 2023-03-14, under 510(k) number K213247.

Who is the listed applicant for JETT PLASMA Medical II?

The FDA 510(k) record lists Compex, Spol, S.R.O. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JETT PLASMA Medical II?

The FDA product code for JETT PLASMA Medical II is QVJ.

Other records listing Compex, Spol, S.R.O. 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.

K240311JETT Medical II

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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.