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)

KLS Martin Individual Patient Solutions

K-Number: K191028 · 2019-11-22

Decision Date2019-11-22
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

KLS Martin Individual Patient Solutions is the device name listed in this FDA 510(k) record. The listed applicant is KLS-Martin L.P.. It received FDA 510(k) clearance on 2019-11-22 under 510(k) number K191028. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KLS Martin Individual Patient Solutions?

KLS Martin Individual Patient Solutions is a medical device that received FDA 510(k) clearance on 2019-11-22. The listed applicant is KLS-Martin L.P.. The 510(k) number is K191028.

When did KLS Martin Individual Patient Solutions receive FDA 510(k) clearance?

KLS Martin Individual Patient Solutions received FDA 510(k) clearance on 2019-11-22, under 510(k) number K191028.

Who is the listed applicant for KLS Martin Individual Patient Solutions?

The FDA 510(k) record lists KLS-Martin L.P. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KLS Martin Individual Patient Solutions?

The FDA product code for KLS Martin Individual Patient Solutions is JEY.

Other records listing KLS-Martin L.P. 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.

View all 32 devices →

Related Devices (Code: JEY)

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.