FDA 510(k)

MPS RESERVOIR BAG

K-Number: K982048 · 1998-07-27

Decision Date1998-07-27

Product CodeKPE

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

MPS RESERVOIR BAG is the device name listed in this FDA 510(k) record. The listed applicant is Medical Product Specialists. It received FDA 510(k) clearance on 1998-07-27 under 510(k) number K982048. The device is classified under product code KPE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MPS RESERVOIR BAG?

MPS RESERVOIR BAG is a medical device that received FDA 510(k) clearance on 1998-07-27. The listed applicant is Medical Product Specialists. The 510(k) number is K982048.

When did MPS RESERVOIR BAG receive FDA 510(k) clearance?

MPS RESERVOIR BAG received FDA 510(k) clearance on 1998-07-27, under 510(k) number K982048.

Who is the listed applicant for MPS RESERVOIR BAG?

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

What is the FDA product code for MPS RESERVOIR BAG?

The FDA product code for MPS RESERVOIR BAG is KPE.

Related Clinical Trials

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Other records listing Medical Product Specialists as applicant

K982587MPS FIXED FLOW RATE SET K982047MPS HUBER NEEDLE EXTENSION SET K895367INTRAVENOUS EXTENSION SET

Related Devices (Code: KPE)

K252079Disposable Infusion Bag for Parenteral NutritionBeijing L&Z Medical Technology Development Co., Ltd.K251980ClaveQS™ BagIcu Medical, Inc.K251139KabiHelp® Uno; KabiHelp® Advance plusFresenius Kabi AG K252094eZSURE™ Empty Fluid ContainerEpic Medical Pte. , Ltd.K250459DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container SolutionTechnoflex Sas.K241442eZSURE™ Empty Fluid Container with ProSeal™ Injection SiteEpic Medical Pte. , Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.