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FDA 510(k)

DISPOSABLE BAG DECANTER

K-Number: K934179 · 1994-05-23

ApplicantByron Medical
Decision Date1994-05-23
Product CodeKPE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE BAG DECANTER is the device name listed in this FDA 510(k) record. The listed applicant is Byron Medical. It received FDA 510(k) clearance on 1994-05-23 under 510(k) number K934179. 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 DISPOSABLE BAG DECANTER?

DISPOSABLE BAG DECANTER is a medical device that received FDA 510(k) clearance on 1994-05-23. The listed applicant is Byron Medical. The 510(k) number is K934179.

When did DISPOSABLE BAG DECANTER receive FDA 510(k) clearance?

DISPOSABLE BAG DECANTER received FDA 510(k) clearance on 1994-05-23, under 510(k) number K934179.

Who is the listed applicant for DISPOSABLE BAG DECANTER?

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

What is the FDA product code for DISPOSABLE BAG DECANTER?

The FDA product code for DISPOSABLE BAG DECANTER is KPE.

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Other records listing Byron Medical 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.

K040149PSI-TEC PERISTALTIC INFILTRATION PUMPK001803ACCELERATOR RECIPROCATING CANNULAK981215PSI-TEC LIPOSUCTION ASPIRATORK981172LIPOPLASTY/ LIPOSUCTION ASPIRATION AND TUMESCENT INFUSION CANNULAE AND NEEDLESK980738PSI-TEC SYRINGE INFUSION PUMP AND ACCESSORIES FOR GENERAL FLUID IRRIGAION/INFILTRATIONK980392PSI-TEC ASPIRATOR

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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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