REVERSE OSMOSIS SYSTEM— 510(k) K944493

Name: FDA 510(k) clearance K944493
Creator: U.S. Food and Drug Administration
Published: 1996-02-20

Substantially Equivalent

G.E.M. Water Systems

FDA 510(k) clearance K944493 for REVERSE OSMOSIS SYSTEM, Substantially Equivalent on 1996-02-20. Applicant: G.E.M. Water Systems. Device class: 2.

Clearance details

Applicant: G.E.M. Water Systems
Product code: Code FIP
Device class: Class 2
Regulation: 21 CFR 876.5665
Advisory panel: Gastroenterology, Urology
Date received: 1994-09-13
Decision date: 1996-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cypress, CA, US

Download summary PDF View on FDA.gov ↗

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K970674 — G.E.M. WATER SYSTEMS, INTERNATIONAL1997-11-19
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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.