WATER CONDUCTIVITY MONITOR & CONTROLLER— 510(k) K800305

Name: FDA 510(k) clearance K800305
Creator: U.S. Food and Drug Administration
Published: 1980-04-08

Substantially Equivalent

Darco Water Systems, Inc.

FDA 510(k) clearance K800305 for WATER CONDUCTIVITY MONITOR & CONTROLLER, Substantially Equivalent on 1980-04-08. Applicant: Darco Water Systems, Inc.. Device class: 2.

Clearance details

Applicant: Darco Water Systems, Inc.
Product code: Code FIP
Device class: Class 2
Regulation: 21 CFR 876.5665
Advisory panel: Gastroenterology, Urology
Date received: 1980-02-01
Decision date: 1980-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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K251851 — DIASAFEplusUS (F00013010)2025-10-09
K252181 — AquaA2025-09-09
K250514 — UPT Series Medical RO Water Treatment System2025-03-17
K232953 — AquaBplus; AquaB LITE2024-06-13

Adverse events under product code FIP

product code FIP

Malfunction: 490
Total: 490

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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