PENTAX EPK-I5020 VIDEO PROCESSOR
FDA 510(k) clearance K113873 · decided 2012-06-22
Clearance details
- K-number
- K113873
- Device name
- PENTAX EPK-I5020 VIDEO PROCESSOR
- Applicant
- Pentax of America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-12-30
- Decision date
- 2012-06-22
- Days to decision
- 175 days
- Clearance type
- Traditional
- Product code
- FET
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- West Cadwell, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.