TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear)
K-Number: K223108 · 2023-01-19
ApplicantMedos International SARL
Decision Date2023-01-19
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear) is a medical device manufactured by Medos International SARL. It received FDA 510(k) clearance on 2023-01-19 under approval number K223108. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear)?
TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear) is a medical device that received FDA 510(k) clearance on 2023-01-19. It is manufactured by Medos International SARL. The 510(k) number is K223108.
When was TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear) approved by the FDA?
TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear) received FDA 510(k) clearance on 2023-01-19, under approval number K223108.
What company makes TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear)?
TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear) is manufactured by Medos International SARL.
What is the FDA product code for TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear)?
The FDA product code for TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear) is OLO.
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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.