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FDA 510(k)

NRFit Syringe

K-Number: K181374 · 2018-12-14

Decision Date2018-12-14
Product CodeQEH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NRFit Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Caina Medical Co.,Ltd. It received FDA 510(k) clearance on 2018-12-14 under 510(k) 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. The listed applicant is Jiangsu Caina Medical Co.,Ltd. The 510(k) number is K181374.

When did NRFit Syringe receive FDA 510(k) clearance?

NRFit Syringe received FDA 510(k) clearance on 2018-12-14, under 510(k) number K181374.

Who is the listed applicant for NRFit Syringe?

The FDA 510(k) record lists Jiangsu Caina Medical Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NRFit Syringe?

The FDA product code for NRFit Syringe is QEH.

Other records listing Jiangsu Caina Medical Co.,Ltd as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 15 devices →

Related Devices (Code: QEH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.