LIBERTY VALVE— 510(k) K964690

Substantially Equivalent

Cleveland Medical Devices, Inc.

FDA 510(k) clearance K964690 for LIBERTY VALVE, Substantially Equivalent on 1997-03-21. Applicant: Cleveland Medical Devices, Inc.. Device class: 2.

Clearance details

Applicant
Cleveland Medical Devices, Inc.
Product code
Code KNX
Device class
Class 2
Regulation
21 CFR 876.5250
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Cleveland, OH, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code KNX

product code KNX
Malfunction
1,064
Total
1,064

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 →

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