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FDA 510(k)

Safety Blood Collection Device for Single Use

K-Number: K170276 · 2017-12-11

ApplicantGemtier Medical (Shanghai), Inc.
Decision Date2017-12-11
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Safety Blood Collection Device for Single Use is a medical device manufactured by Gemtier Medical (Shanghai), Inc.. It received FDA 510(k) clearance on 2017-12-11 under approval number K170276. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Safety Blood Collection Device for Single Use?

Safety Blood Collection Device for Single Use is a medical device that received FDA 510(k) clearance on 2017-12-11. It is manufactured by Gemtier Medical (Shanghai), Inc.. The 510(k) number is K170276.

When was Safety Blood Collection Device for Single Use approved by the FDA?

Safety Blood Collection Device for Single Use received FDA 510(k) clearance on 2017-12-11, under approval number K170276.

What company makes Safety Blood Collection Device for Single Use?

Safety Blood Collection Device for Single Use is manufactured by Gemtier Medical (Shanghai), Inc..

What is the FDA product code for Safety Blood Collection Device for Single Use?

The FDA product code for Safety Blood Collection Device for Single Use is FMI.

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Related PubMed Literature

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Other Devices by Gemtier Medical (Shanghai), Inc.

K192679Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use K202493Medical Face Mask K202331Medical Face Mask K212652Sterile Syringe with Fixed Safety Needle for Single Use

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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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