DeviceClearance

FRESENIUS NATURALYTE LIQUID ACID CONCENTRATE, 9000, 6000 AND 4000 SERIES— 510(k) K070177

Substantially Equivalent

Fresenius Medical Care North America

FDA 510(k) clearance K070177 for FRESENIUS NATURALYTE LIQUID ACID CONCENTRATE, 9000, 6000 AND 4000 SERIES, Substantially Equivalent on 2007-03-29. Applicant: Fresenius Medical Care North America. Device class: 2.

Clearance details

Applicant
Fresenius Medical Care North America
Product code
Code KPO
Device class
Class 2
Regulation
21 CFR 876.5820
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Waltham, MA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code KPO

product code KPO
Death
14
Malfunction
775
Other
20
Total
809

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K070177

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K070177.

Data sourced from openFDA. This site is unofficial and independent of the FDA.