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FDA 510(k)

SINGLE DOSE DISPENSING PIN, MODEL 2201

K-Number: K013087 · 2001-11-13

ApplicantAlaris Medical Systems, Inc.
Decision Date2001-11-13
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SINGLE DOSE DISPENSING PIN, MODEL 2201 is the device name listed in this FDA 510(k) record. The listed applicant is Alaris Medical Systems, Inc.. It received FDA 510(k) clearance on 2001-11-13 under 510(k) number K013087. 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 SINGLE DOSE DISPENSING PIN, MODEL 2201?

SINGLE DOSE DISPENSING PIN, MODEL 2201 is a medical device that received FDA 510(k) clearance on 2001-11-13. The listed applicant is Alaris Medical Systems, Inc.. The 510(k) number is K013087.

When did SINGLE DOSE DISPENSING PIN, MODEL 2201 receive FDA 510(k) clearance?

SINGLE DOSE DISPENSING PIN, MODEL 2201 received FDA 510(k) clearance on 2001-11-13, under 510(k) number K013087.

Who is the listed applicant for SINGLE DOSE DISPENSING PIN, MODEL 2201?

The FDA 510(k) record lists Alaris Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SINGLE DOSE DISPENSING PIN, MODEL 2201?

The FDA product code for SINGLE DOSE DISPENSING PIN, MODEL 2201 is LHI.

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Other records listing Alaris Medical Systems, Inc. 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.

K043299MEDLEY PCA MODULE, MODEL 8120K041241MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600K031741MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300K032233MEDLEY PCA MODULE, MODEL 8120K032147SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 70XX, 71XX, 72XX, 7XXXX SERIESK030459MEDLEY SYSTEM WITH MEDICATION MANAGEMENT SYSTEM (MMS)

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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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