Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Chromix

K-Number: K261473 · 2026-07-01

Decision Date2026-07-01
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Chromix is the device name listed in this FDA 510(k) record. The listed applicant is Termosalud S.L.. It received FDA 510(k) clearance on 2026-07-01 under 510(k) number K261473. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Chromix?

Chromix is a medical device that received FDA 510(k) clearance on 2026-07-01. The listed applicant is Termosalud S.L.. The 510(k) number is K261473.

When did Chromix receive FDA 510(k) clearance?

Chromix received FDA 510(k) clearance on 2026-07-01, under 510(k) number K261473.

Who is the listed applicant for Chromix?

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

What is the FDA product code for Chromix?

The FDA product code for Chromix is OHS.

Other records listing Termosalud S.L. 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.

Related Devices (Code: OHS)

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.

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.