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FDA 510(k)

UNILYTE A

K-Number: K843623 · 1984-11-16

ApplicantMedical Enterprises, Ltd.
Decision Date1984-11-16
Product CodeFKQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

UNILYTE A is the device name listed in this FDA 510(k) record. The listed applicant is Medical Enterprises, Ltd.. It received FDA 510(k) clearance on 1984-11-16 under 510(k) number K843623. The device is classified under product code FKQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNILYTE A?

UNILYTE A is a medical device that received FDA 510(k) clearance on 1984-11-16. The listed applicant is Medical Enterprises, Ltd.. The 510(k) number is K843623.

When did UNILYTE A receive FDA 510(k) clearance?

UNILYTE A received FDA 510(k) clearance on 1984-11-16, under 510(k) number K843623.

Who is the listed applicant for UNILYTE A?

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

What is the FDA product code for UNILYTE A?

The FDA product code for UNILYTE A is FKQ.

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Related Devices (Code: FKQ)

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.

K052764DIACAP ULTRA DIALYSIS FLUID FILTERB. Braun Medizintechnologie GmbHK893612TWO TANK DISSOLUTION MODULENational Medical Care, Medical Products Div., Inc.K874084MULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAKS) #IDMNational Medical Care, Medical Products Div., Inc.K873421KAWASUMI A.V. FISTULA SETKawasumi Laboratories Co., Ltd.K870889ACID FUCHSIN SOLUTIONSD.R.G. Scientific IndustriesK861730ACTRIL FOR KIDNEY MACHINE DISINFECTANTRenal Systems, Inc.

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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