EXTRAPURE REVERSE OSMOSIS WATER UNIT— 510(k) K822385

Substantially Equivalent

Extracorporeal Medical Specialities, Inc.

FDA 510(k) clearance K822385 for EXTRAPURE REVERSE OSMOSIS WATER UNIT, Substantially Equivalent on 1982-10-13. Applicant: Extracorporeal Medical Specialities, Inc..

Clearance details

Applicant: Extracorporeal Medical Specialities, Inc.
Product code: Code FIP
Advisory panel: Gastroenterology, Urology
Date received: 1982-08-09
Decision date: 1982-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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.