PENTAX Medical EPK-3000 Video Imaging System— 510(k) K182846
Substantially EquivalentPentax of America, Inc.
FDA 510(k) clearance K182846 for PENTAX Medical EPK-3000 Video Imaging System, Substantially Equivalent on 2019-01-09. Applicant: Pentax of America, Inc.. Device class: 2.
Clearance details
- Applicant
- Pentax of America, Inc.
- Product code
- Code EOB
- Device class
- Class 2
- Regulation
- 21 CFR 874.4760
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Montvale, NJ, US
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More clearances from Pentax of America, Inc.
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- K241213 — PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL)
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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.