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FDA 510(k)

ERI-FLO 900 DIALYZER

K-Number: K760702 · 1976-11-19

ApplicantErika, Inc.
Decision Date1976-11-19
Product CodeFHS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ERI-FLO 900 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 1976-11-19 under 510(k) number K760702. 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 ERI-FLO 900 DIALYZER?

ERI-FLO 900 DIALYZER is a medical device that received FDA 510(k) clearance on 1976-11-19. The listed applicant is Erika, Inc.. The 510(k) number is K760702.

When did ERI-FLO 900 DIALYZER receive FDA 510(k) clearance?

ERI-FLO 900 DIALYZER received FDA 510(k) clearance on 1976-11-19, under 510(k) number K760702.

Who is the listed applicant for ERI-FLO 900 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 ERI-FLO 900 DIALYZER?

The FDA product code for ERI-FLO 900 DIALYZER is FHS.

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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

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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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