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FDA 510(k)

BEDSIDE CONSOLES (11-3-910 & 11-3-930)

K-Number: K760965 · 1976-12-06

ApplicantSeattle Artificial Kidney Supply Co.
Decision Date1976-12-06
Product CodeFKQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BEDSIDE CONSOLES (11-3-910 & 11-3-930) is the device name listed in this FDA 510(k) record. The listed applicant is Seattle Artificial Kidney Supply Co.. It received FDA 510(k) clearance on 1976-12-06 under 510(k) number K760965. 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 BEDSIDE CONSOLES (11-3-910 & 11-3-930)?

BEDSIDE CONSOLES (11-3-910 & 11-3-930) is a medical device that received FDA 510(k) clearance on 1976-12-06. The listed applicant is Seattle Artificial Kidney Supply Co.. The 510(k) number is K760965.

When did BEDSIDE CONSOLES (11-3-910 & 11-3-930) receive FDA 510(k) clearance?

BEDSIDE CONSOLES (11-3-910 & 11-3-930) received FDA 510(k) clearance on 1976-12-06, under 510(k) number K760965.

Who is the listed applicant for BEDSIDE CONSOLES (11-3-910 & 11-3-930)?

The FDA 510(k) record lists Seattle Artificial Kidney Supply Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BEDSIDE CONSOLES (11-3-910 & 11-3-930)?

The FDA product code for BEDSIDE CONSOLES (11-3-910 & 11-3-930) 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

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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