DeviceClearance

CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES— 510(k) K111047

Substantially Equivalent

Mauna Kea Technologies, Inc.

FDA 510(k) clearance K111047 for CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES, Substantially Equivalent on 2011-08-08. Applicant: Mauna Kea Technologies, Inc.. Device class: 2.

Clearance details

Applicant
Mauna Kea Technologies, Inc.
Product code
Code OWN
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Newton, PA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code OWN

product code OWN
Malfunction
1,286
Total
1,286

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.