PENTAX EPK-I5010 VIDEO PROCESSOR
FDA 510(k) clearance K122470 · decided 2013-04-10
Clearance details
- K-number
- K122470
- Device name
- PENTAX EPK-I5010 VIDEO PROCESSOR
- Applicant
- Pentax Medical
- Decision
- Substantially Equivalent
- Date received
- 2012-08-13
- Decision date
- 2013-04-10
- Days to decision
- 240 days
- Clearance type
- Traditional
- Product code
- PEA
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Montvale, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.