PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT Imaging System with Camera Head PVK-J10— 510(k) K220465
Substantially EquivalentPentax of America, Inc.
FDA 510(k) clearance K220465 for PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT Imaging System with Camera Head PVK-J10, Substantially Equivalent on 2022-11-16. Applicant: Pentax of America, Inc..
Clearance details
- Applicant
- Pentax of America, Inc.
- Product code
- Code EOB
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Montvale, NJ, US
Adverse events under product code EOB
product code EOB- Malfunction
- 6,143
- Total
- 6,143
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.