FDA 510(k)

Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL)

Numéro K : K181426 · 2018-10-11

DemandeurJiangsu Micsafe Medical Technology Co., Ltd.

Date de décision2018-10-11

Code produitPNR

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL) is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Micsafe Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-10-11 under 510(k) number K181426. The device is classified under product code PNR. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL)?

Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL) is a medical device that received FDA 510(k) clearance on 2018-10-11. The listed applicant is Jiangsu Micsafe Medical Technology Co., Ltd.. The 510(k) number is K181426.

When did Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL) receive FDA 510(k) clearance?

Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL) received FDA 510(k) clearance on 2018-10-11, under 510(k) number K181426.

Who is the listed applicant for Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL)?

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

What is the FDA product code for Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL)?

The FDA product code for Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL) is PNR.

Essais cliniques associés

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Dispositifs connexes (Code : PNR)

Source officielle

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