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FDA 510(k)

TELIGEN System

K-Number: K213978 · 2022-10-18

ApplicantMedos International SARL
Decision Date2022-10-18
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TELIGEN System is the device name listed in this FDA 510(k) record. The listed applicant is Medos International SARL. It received FDA 510(k) clearance on 2022-10-18 under 510(k) number K213978. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TELIGEN System?

TELIGEN System is a medical device that received FDA 510(k) clearance on 2022-10-18. The listed applicant is Medos International SARL. The 510(k) number is K213978.

When did TELIGEN System receive FDA 510(k) clearance?

TELIGEN System received FDA 510(k) clearance on 2022-10-18, under 510(k) number K213978.

Who is the listed applicant for TELIGEN System?

The FDA 510(k) record lists Medos International SARL as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TELIGEN System?

The FDA product code for TELIGEN System is HRX.

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Related Devices (Code: HRX)

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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.

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