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FDA 510(k)

BICARBONATE/VARIABLE SODIUM KIT-DM-367

K-Number: K830908 · 1983-06-08

ApplicantExtracorporeal Medical Specialities, Inc.
Decision Date1983-06-08
Product CodeFKQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BICARBONATE/VARIABLE SODIUM KIT-DM-367 is the device name listed in this FDA 510(k) record. The listed applicant is Extracorporeal Medical Specialities, Inc.. It received FDA 510(k) clearance on 1983-06-08 under 510(k) number K830908. 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 BICARBONATE/VARIABLE SODIUM KIT-DM-367?

BICARBONATE/VARIABLE SODIUM KIT-DM-367 is a medical device that received FDA 510(k) clearance on 1983-06-08. The listed applicant is Extracorporeal Medical Specialities, Inc.. The 510(k) number is K830908.

When did BICARBONATE/VARIABLE SODIUM KIT-DM-367 receive FDA 510(k) clearance?

BICARBONATE/VARIABLE SODIUM KIT-DM-367 received FDA 510(k) clearance on 1983-06-08, under 510(k) number K830908.

Who is the listed applicant for BICARBONATE/VARIABLE SODIUM KIT-DM-367?

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

What is the FDA product code for BICARBONATE/VARIABLE SODIUM KIT-DM-367?

The FDA product code for BICARBONATE/VARIABLE SODIUM KIT-DM-367 is FKQ.

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Other records listing Extracorporeal Medical Specialities, 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.

K843955EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATORK840262HANCOCK PERICARDIAL PATCHK840532HEMOPERFUSION SYSTEM TP-400K840057EXP* 500 PARALLEL PLATE DIALYZERK840146EXP* 700 PARALLEL PLATE DIALYZERK832547ULTRAFILTRATION CONTROLLER

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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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