PORTABLE SERIES REVERSE OSMOSIS SYSTEMS 700, 701, 702, 703, 704, 750, MRE-NF, F800-F802, RO SECURA, REVERSE OSMOSIS SYST— 510(k) K964539

Name: FDA 510(k) clearance K964539
Creator: U.S. Food and Drug Administration
Published: 1997-11-26

Substantially Equivalent

Zyzatech Water Systems, Inc.

FDA 510(k) clearance K964539 for PORTABLE SERIES REVERSE OSMOSIS SYSTEMS 700, 701, 702, 703, 704, 750, MRE-NF, F800-F802, RO SECURA, REVERSE OSMOSIS SYST, Substantially Equivalent on 1997-11-26. Applicant: Zyzatech Water Systems, Inc.. Device class: 2.

Clearance details

Applicant: Zyzatech Water Systems, Inc.
Product code: Code FIP
Device class: Class 2
Regulation: 21 CFR 876.5665
Advisory panel: Gastroenterology, Urology
Date received: 1996-11-12
Decision date: 1997-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kent, WA, US

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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.