NRFit Syringe
K-Number: K181374 · 2018-12-14
ApplicantJiangsu Caina Medical Co.,Ltd
Decision Date2018-12-14
Product CodeQEH
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
NRFit Syringe is a medical device manufactured by Jiangsu Caina Medical Co.,Ltd. It received FDA 510(k) clearance on 2018-12-14 under approval number K181374. 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 NRFit Syringe?
NRFit Syringe is a medical device that received FDA 510(k) clearance on 2018-12-14. It is manufactured by Jiangsu Caina Medical Co.,Ltd. The 510(k) number is K181374.
When was NRFit Syringe approved by the FDA?
NRFit Syringe received FDA 510(k) clearance on 2018-12-14, under approval number K181374.
What company makes NRFit Syringe?
NRFit Syringe is manufactured by Jiangsu Caina Medical Co.,Ltd.
What is the FDA product code for NRFit Syringe?
The FDA product code for NRFit Syringe is QEH.
Other Devices by Jiangsu Caina Medical Co.,Ltd
K172938Disposable Sterile Needle
K191490Retractable Safety Syringe, Retractable Safety Insulin Syringe, Retractable Safety Tuberculin Syringe, Retractable Safety Allergy Syringe
K190502ENFit Oral / Enteral Syringe
K200027Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter
K193022Retractable Safety Insulin Syringe
K193526Syringe with safety needle, Safety needle
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.