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FDA 510(k)

TUF TRACK MODEL TT83 CUBICLE TRACK & IV83 INTR TRK

K-Number: K852938 · 1985-09-30

ApplicantNorthern Customfab, Inc.
Decision Date1985-09-30
Product CodeKPE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TUF TRACK MODEL TT83 CUBICLE TRACK & IV83 INTR TRK is the device name listed in this FDA 510(k) record. The listed applicant is Northern Customfab, Inc.. It received FDA 510(k) clearance on 1985-09-30 under 510(k) number K852938. 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 TUF TRACK MODEL TT83 CUBICLE TRACK & IV83 INTR TRK?

TUF TRACK MODEL TT83 CUBICLE TRACK & IV83 INTR TRK is a medical device that received FDA 510(k) clearance on 1985-09-30. The listed applicant is Northern Customfab, Inc.. The 510(k) number is K852938.

When did TUF TRACK MODEL TT83 CUBICLE TRACK & IV83 INTR TRK receive FDA 510(k) clearance?

TUF TRACK MODEL TT83 CUBICLE TRACK & IV83 INTR TRK received FDA 510(k) clearance on 1985-09-30, under 510(k) number K852938.

Who is the listed applicant for TUF TRACK MODEL TT83 CUBICLE TRACK & IV83 INTR TRK?

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

What is the FDA product code for TUF TRACK MODEL TT83 CUBICLE TRACK & IV83 INTR TRK?

The FDA product code for TUF TRACK MODEL TT83 CUBICLE TRACK & IV83 INTR TRK is KPE.

Related Clinical Trials

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.

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Other records listing Northern Customfab, 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.

K852937THE IVY POLE-INTRAVENOUS BOT TREES #1121K & 1221K

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

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

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