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

Substantially Equivalent

Zyzatech Water Systems, Inc.

Clearance details

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

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.