DIALYZER (MODEL 1850)— 510(k) K760374

Substantially Equivalent

Erika, Inc.

FDA 510(k) clearance K760374 for DIALYZER (MODEL 1850), Substantially Equivalent on 1976-10-27. Applicant: Erika, Inc.. Device class: 2.

Clearance details

Applicant: Erika, Inc.
Product code: Code FHS
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1976-08-05
Decision date: 1976-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Recent devices under product code FHS

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K801634 — THE VITA 2 DISPOSABLE DIALYZER1980-12-17
K800723 — MICRO-COIL 100 COIL DIALYZER1980-05-14
K800174 — GAMBRO LUNDIA COIL DIALYZER1980-02-13

More clearances from Erika, Inc.

K853134 — NATIONAL MED CARE INFUSION PUMP ADM SET #95-0001-81985-11-06
K852309 — ERIKA ART LI, 3-9621-8, 22-6, 23-4 & VEN 9714-11985-07-26
K852310 — NATURALYTE BICARBONATE CONCENTRATE-DRY PACK1985-07-26
K850865 — TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1-1985-04-03
K850866 — TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1L1985-04-03

Data sourced from openFDA. This site is unofficial and independent of the FDA.