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FDA 510(k)

PRESSURE INFUSOR FOR I.V. BAGS/AUTOINFLATION

K-Number: K890268 · 1989-05-05

ApplicantBiomedical Dynamics, Inc.
Decision Date1989-05-05
Product CodeKPE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PRESSURE INFUSOR FOR I.V. BAGS/AUTOINFLATION is the device name listed in this FDA 510(k) record. The listed applicant is Biomedical Dynamics, Inc.. It received FDA 510(k) clearance on 1989-05-05 under 510(k) number K890268. 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 PRESSURE INFUSOR FOR I.V. BAGS/AUTOINFLATION?

PRESSURE INFUSOR FOR I.V. BAGS/AUTOINFLATION is a medical device that received FDA 510(k) clearance on 1989-05-05. The listed applicant is Biomedical Dynamics, Inc.. The 510(k) number is K890268.

When did PRESSURE INFUSOR FOR I.V. BAGS/AUTOINFLATION receive FDA 510(k) clearance?

PRESSURE INFUSOR FOR I.V. BAGS/AUTOINFLATION received FDA 510(k) clearance on 1989-05-05, under 510(k) number K890268.

Who is the listed applicant for PRESSURE INFUSOR FOR I.V. BAGS/AUTOINFLATION?

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

What is the FDA product code for PRESSURE INFUSOR FOR I.V. BAGS/AUTOINFLATION?

The FDA product code for PRESSURE INFUSOR FOR I.V. BAGS/AUTOINFLATION is KPE.

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Other records listing Biomedical Dynamics, 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.

K915074IRRIGATOR/ASPIRATOR PROBEK913751PRESSURE INFUSERK911213CUFFABLEK911216INFUSABLEK911324IRRIGATION/ASPIRATION TUBING SETK904376ANEROID BLOOD PRESSURE GAUGE

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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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