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FDA 510(k)

B Dispensing Line

K-Number: K203674 · 2021-09-27

ApplicantAea Srl
Decision Date2021-09-27
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

B Dispensing Line is the device name listed in this FDA 510(k) record. The listed applicant is Aea Srl. It received FDA 510(k) clearance on 2021-09-27 under 510(k) number K203674. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the B Dispensing Line?

B Dispensing Line is a medical device that received FDA 510(k) clearance on 2021-09-27. The listed applicant is Aea Srl. The 510(k) number is K203674.

When did B Dispensing Line receive FDA 510(k) clearance?

B Dispensing Line received FDA 510(k) clearance on 2021-09-27, under 510(k) number K203674.

Who is the listed applicant for B Dispensing Line?

The FDA 510(k) record lists Aea Srl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for B Dispensing Line?

The FDA product code for B Dispensing Line is LHI.

Other records listing Aea Srl 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.

K192770S dispensing line

Related Devices (Code: LHI)

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.

K252987ADRx™ Admixture DeviceEpic Medical Pte. , Ltd.K260301Vial AdapterHangzhou Qiantang Longyue Biotechnology Co., Ltd.K250345Medline Bag DecanterMedline Industries, LPK251715FlowArt® Vial Access Device VentedAsset MedikalK251676Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S)Microtek Medical, LLCK243404HyHub™ and HyHub™ Duo Vial Access DevicesTakeda Pharmaceuticals

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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