EMPTY DIALYSATE CONTAINER— 510(k) K831689

Substantially Equivalent

Delmed, Inc.

FDA 510(k) clearance K831689 for EMPTY DIALYSATE CONTAINER, Substantially Equivalent on 1983-08-11. Applicant: Delmed, Inc.. Device class: 1.

Clearance details

Applicant: Delmed, Inc.
Product code: Code FKK
Device class: Class 1
Regulation: 21 CFR 876.4730
Advisory panel: Gastroenterology, Urology
Date received: 1983-05-24
Decision date: 1983-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FKK

K854512 — TUBING CLAMP CAT#1000-A1985-12-02
K854517 — NEW TRAVENOL ROLLER CLAMP-SOLUTION ADMIN. SET1985-12-02
K844121 — CLAMP, TUBING, LINE1984-12-17
K822551 — AMP CAPD UNISPIKE AMINISTRATION SET1982-10-13
K802009 — FLOWCLAMP CAT.#1011 & 10121980-10-31

More clearances from Delmed, Inc.

K895142 — ENTERAL PUMP SET WITH ENTERAL SPIKE1990-10-02
K895329 — 600ML AND 1200ML ENTERAL BAG ADM. SET FOR ENTERA1990-10-02
K895650 — ENTERAL PUMP SET W/ENTERA-FLO SPIKE1990-10-02
K894506 — ENTERA-FLO ENTERAL FEEDING PUMP1990-08-06
K901477 — DELMED 80/2 DIALYSIS SYSTEM W/ULTRAFILTRATION1990-07-27

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