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FDA 510(k)

TELEMIS-MEDICAL SOLUTION

K-Number: K032157 · 2003-09-24

ApplicantTelemis S.A.
Decision Date2003-09-24
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TELEMIS-MEDICAL SOLUTION is the device name listed in this FDA 510(k) record. The listed applicant is Telemis S.A.. It received FDA 510(k) clearance on 2003-09-24 under 510(k) number K032157. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TELEMIS-MEDICAL SOLUTION?

TELEMIS-MEDICAL SOLUTION is a medical device that received FDA 510(k) clearance on 2003-09-24. The listed applicant is Telemis S.A.. The 510(k) number is K032157.

When did TELEMIS-MEDICAL SOLUTION receive FDA 510(k) clearance?

TELEMIS-MEDICAL SOLUTION received FDA 510(k) clearance on 2003-09-24, under 510(k) number K032157.

Who is the listed applicant for TELEMIS-MEDICAL SOLUTION?

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

What is the FDA product code for TELEMIS-MEDICAL SOLUTION?

The FDA product code for TELEMIS-MEDICAL SOLUTION is LLZ.

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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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