IOCARE CONVERTER KIT— 510(k) K843276

Substantially Equivalent

Chiron Vision Corp.

FDA 510(k) clearance K843276 for IOCARE CONVERTER KIT, Substantially Equivalent on 1985-05-09. Applicant: Chiron Vision Corp..

Clearance details

Applicant
Chiron Vision Corp.
Product code
Code HQC
Advisory panel
Ophthalmic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Irvine, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code HQC

product code HQC
Injury
2,378
Malfunction
8,768
Total
11,146

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.