HD-100 HEMODIALYSIS SYSTEMS AND ACCESSORIES— 510(k) K863720

Substantially Equivalent

Water Pure, Inc.

FDA 510(k) clearance K863720 for HD-100 HEMODIALYSIS SYSTEMS AND ACCESSORIES, Substantially Equivalent on 1986-10-29. Applicant: Water Pure, Inc..

Clearance details

Applicant: Water Pure, Inc.
Product code: Code FIP
Advisory panel: Gastroenterology, Urology
Date received: 1986-09-23
Decision date: 1986-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Louisville, KY, 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.