Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type)
K-Number: K202319 · 2021-11-12
ApplicantTianjin Huahong Technology Co., Ltd.
Decision Date2021-11-12
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type) is a medical device manufactured by Tianjin Huahong Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-11-12 under approval number K202319. 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 Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type)?
Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type) is a medical device that received FDA 510(k) clearance on 2021-11-12. It is manufactured by Tianjin Huahong Technology Co., Ltd.. The 510(k) number is K202319.
When was Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type) approved by the FDA?
Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type) received FDA 510(k) clearance on 2021-11-12, under approval number K202319.
What company makes Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type)?
Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type) is manufactured by Tianjin Huahong Technology Co., Ltd..
What is the FDA product code for Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type)?
The FDA product code for Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type) is FMI.
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Related PubMed Literature
Other Devices by Tianjin Huahong Technology Co., Ltd.
K220475Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T)
K221176Insulin Pen Needle
K220370Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI)
K220372Heel Stick Safety Lancet (HHZ-II, HHZ-III)
K243306Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); Lancing device (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T, HH-XXVII-T)
K241627Safety Lancet (XXXV)
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Official Source
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