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

FDA 510(k)

Artiglass NRFitTM Tip L.O.R. Glass Syringes

K-Number: K213800 · 2022-05-19

ApplicantArtiglass Srl
Decision Date2022-05-19
Product CodeQEH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Artiglass NRFitTM Tip L.O.R. Glass Syringes is a medical device manufactured by Artiglass Srl. It received FDA 510(k) clearance on 2022-05-19 under approval number K213800. The device is classified under product code QEH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Artiglass NRFitTM Tip L.O.R. Glass Syringes?

Artiglass NRFitTM Tip L.O.R. Glass Syringes is a medical device that received FDA 510(k) clearance on 2022-05-19. It is manufactured by Artiglass Srl. The 510(k) number is K213800.

When was Artiglass NRFitTM Tip L.O.R. Glass Syringes approved by the FDA?

Artiglass NRFitTM Tip L.O.R. Glass Syringes received FDA 510(k) clearance on 2022-05-19, under approval number K213800.

What company makes Artiglass NRFitTM Tip L.O.R. Glass Syringes?

Artiglass NRFitTM Tip L.O.R. Glass Syringes is manufactured by Artiglass Srl.

What is the FDA product code for Artiglass NRFitTM Tip L.O.R. Glass Syringes?

The FDA product code for Artiglass NRFitTM Tip L.O.R. Glass Syringes is QEH.

Related Devices (Code: QEH)

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.