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FDA 510(k)

MODIFICATION TO KIDNEY DIALYZER

K-Number: K771349 · 1977-08-02

ApplicantErika, Inc.
Decision Date1977-08-02
Product CodeFHS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO KIDNEY DIALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Erika, Inc.. It received FDA 510(k) clearance on 1977-08-02 under 510(k) number K771349. The device is classified under product code FHS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO KIDNEY DIALYZER?

MODIFICATION TO KIDNEY DIALYZER is a medical device that received FDA 510(k) clearance on 1977-08-02. The listed applicant is Erika, Inc.. The 510(k) number is K771349.

When did MODIFICATION TO KIDNEY DIALYZER receive FDA 510(k) clearance?

MODIFICATION TO KIDNEY DIALYZER received FDA 510(k) clearance on 1977-08-02, under 510(k) number K771349.

Who is the listed applicant for MODIFICATION TO KIDNEY DIALYZER?

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 MODIFICATION TO KIDNEY DIALYZER?

The FDA product code for MODIFICATION TO KIDNEY DIALYZER is FHS.

Related Clinical Trials

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Other records listing Erika, 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.

K853134NATIONAL MED CARE INFUSION PUMP ADM SET #95-0001-8K852310NATURALYTE BICARBONATE CONCENTRATE-DRY PACKK852309ERIKA ART LI, 3-9621-8, 22-6, 23-4 & VEN 9714-1K850866TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1LK850865TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1-K850654TORAY INDUS. FILTRYZER HOLLOW FIBER ARTIFICIAL KID

View all 43 devices →

Related Devices (Code: FHS)

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.

K812811MICROCOIL 80 DIALYZERErika, Inc.K811974MICROCOIL 150 DIALYZERErika, Inc.K801634THE VITA 2 DISPOSABLE DIALYZERBellco Artifidial Organ Spec., Inc.K800723MICRO-COIL 100 COIL DIALYZERErika, Inc.K800174GAMBRO LUNDIA COIL DIALYZERGambro, Inc.K790223DIALYZER, CD-800 COILTravenol Laboratories, S.A.

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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