DeviceClearance

K122470

Substantially Equivalent

PENTAX EPK-I5010 VIDEO PROCESSOR

Applicant
Pentax Medical
Product code
PEA
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Montvale, NJ, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code PEA

product code PEA
Malfunction
515
Total
515

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.