FDA 510(k)

NATURALYTE BICARBONATE DIALYSATE 4400

K-Number: K823115 · 1982-12-03

Decision Date1982-12-03

Product CodeKRO

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

NATURALYTE BICARBONATE DIALYSATE 4400 is the device name listed in this FDA 510(k) record. The listed applicant is Erika, Inc.. It received FDA 510(k) clearance on 1982-12-03 under 510(k) number K823115. The device is classified under product code KRO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NATURALYTE BICARBONATE DIALYSATE 4400?

NATURALYTE BICARBONATE DIALYSATE 4400 is a medical device that received FDA 510(k) clearance on 1982-12-03. The listed applicant is Erika, Inc.. The 510(k) number is K823115.

When did NATURALYTE BICARBONATE DIALYSATE 4400 receive FDA 510(k) clearance?

NATURALYTE BICARBONATE DIALYSATE 4400 received FDA 510(k) clearance on 1982-12-03, under 510(k) number K823115.

Who is the listed applicant for NATURALYTE BICARBONATE DIALYSATE 4400?

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

What is the FDA product code for NATURALYTE BICARBONATE DIALYSATE 4400?

The FDA product code for NATURALYTE BICARBONATE DIALYSATE 4400 is KRO.

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Other records listing Erika, Inc. as applicant

K853134NATIONAL MED CARE INFUSION PUMP ADM SET #95-0001-8 K852310NATURALYTE BICARBONATE CONCENTRATE-DRY PACK K852309ERIKA ART LI, 3-9621-8, 22-6, 23-4 & VEN 9714-1 K850866TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1L K850865TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1-K850654TORAY INDUS. FILTRYZER HOLLOW FIBER ARTIFICIAL KID

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Related Devices (Code: KRO)

K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics K252898Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge BumperHowmedica Osteonics Corp., Dba Stryker Orthopaedics K252303Stem Extension Line (USTAR II System)United Orthopedic Corporation K251665Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics K242871ATTUNE™ Revision Hinge KneeDepuy Ireland UC K240043EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS™ Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; ADVANCE® A-CLASS® Tibial Insert; ADVANCE® Knee System; ADVANCE® Ultra-Congruent Tibial InseMicroport Orthopedics, 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.