TrueCare Biomedix Tamper Evident Cap
K-Number: K210818 · 2021-09-15
Decision Date2021-09-15
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
TrueCare Biomedix Tamper Evident Cap is a medical device manufactured by Us Infusion Inc. D/B/A Truecare Biomedix-USA. It received FDA 510(k) clearance on 2021-09-15 under approval number K210818. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TrueCare Biomedix Tamper Evident Cap?
TrueCare Biomedix Tamper Evident Cap is a medical device that received FDA 510(k) clearance on 2021-09-15. It is manufactured by Us Infusion Inc. D/B/A Truecare Biomedix-USA. The 510(k) number is K210818.
When was TrueCare Biomedix Tamper Evident Cap approved by the FDA?
TrueCare Biomedix Tamper Evident Cap received FDA 510(k) clearance on 2021-09-15, under approval number K210818.
What company makes TrueCare Biomedix Tamper Evident Cap?
TrueCare Biomedix Tamper Evident Cap is manufactured by Us Infusion Inc. D/B/A Truecare Biomedix-USA.
What is the FDA product code for TrueCare Biomedix Tamper Evident Cap?
The FDA product code for TrueCare Biomedix Tamper Evident Cap is FMF.
Related Devices (Code: FMF)
K162180Disposable Insulin SyringeBerpu Medical Technology Co., Ltd.
K162081BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin SyringeBecton, Dickinson and Company
K162602NovoPen EchoNovo Nordisk, Inc.
K161568Bone Solutions Mixing and Delivery SystemBone Solutions, Inc.
K152879Sure-Fine Insulin SyringesShina Med Corporation
K160629InPenCompanion Medical, Inc.
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.