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FDA 510(k)

JETT Medical II

K-Number: K240311 · 2025-01-22

ApplicantCompex, Spol, S.R.O.
Decision Date2025-01-22
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

JETT 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 2025-01-22 under 510(k) number K240311. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JETT Medical II?

JETT Medical II is a medical device that received FDA 510(k) clearance on 2025-01-22. The listed applicant is Compex, Spol, S.R.O.. The 510(k) number is K240311.

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

JETT Medical II received FDA 510(k) clearance on 2025-01-22, under 510(k) number K240311.

Who is the listed applicant for JETT 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 Medical II?

The FDA product code for JETT Medical II is GEI.

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.

K213247JETT PLASMA Medical II

Related Devices (Code: GEI)

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.

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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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