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FDA 510(k)

DELMED IV CONTAINER

K-Number: K830450 · 1983-03-01

ApplicantDelmed, Inc.
Decision Date1983-03-01
Product CodeKPE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DELMED IV CONTAINER is the device name listed in this FDA 510(k) record. The listed applicant is Delmed, Inc.. It received FDA 510(k) clearance on 1983-03-01 under 510(k) number K830450. 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 DELMED IV CONTAINER?

DELMED IV CONTAINER is a medical device that received FDA 510(k) clearance on 1983-03-01. The listed applicant is Delmed, Inc.. The 510(k) number is K830450.

When did DELMED IV CONTAINER receive FDA 510(k) clearance?

DELMED IV CONTAINER received FDA 510(k) clearance on 1983-03-01, under 510(k) number K830450.

Who is the listed applicant for DELMED IV CONTAINER?

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

What is the FDA product code for DELMED IV CONTAINER?

The FDA product code for DELMED IV CONTAINER is KPE.

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Other records listing Delmed, 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.

K895650ENTERAL PUMP SET W/ENTERA-FLO SPIKEK895329600ML AND 1200ML ENTERAL BAG ADM. SET FOR ENTERAK895142ENTERAL PUMP SET WITH ENTERAL SPIKEK894506ENTERA-FLO ENTERAL FEEDING PUMPK901478DELMED 80/2 DIALYSIS SYSTEM W/LAST BAG OPTIONK901477DELMED 80/2 DIALYSIS SYSTEM W/ULTRAFILTRATION

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Related Devices (Code: KPE)

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.

K252079Disposable Infusion Bag for Parenteral NutritionBeijing L&Z Medical Technology Development Co., Ltd.K251980ClaveQS™ BagIcu Medical, Inc.K251139KabiHelp® Uno; KabiHelp® Advance plusFresenius Kabi AGK252094eZSURE™ 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

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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