PENTAX EPK-I5010 VIDEO PROCESSOR— 510(k) K122470
Substantially EquivalentPentax Medical
FDA 510(k) clearance K122470 for PENTAX EPK-I5010 VIDEO PROCESSOR, Substantially Equivalent on 2013-04-10. Applicant: Pentax Medical. Device class: 2.
Clearance details
- Applicant
- Pentax Medical
- Product code
- Code PEA
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Montvale, NJ, US
Recent devices under product code PEA
view all- K251127 — PENTAX Medical Video Processor (EPK-i8020c)
- K231249 — PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cL
- K190805 — PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cL
- K191282 — PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family
- K173679 — PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes
More clearances from Pentax Medical
view allAdverse events under product code PEA
product code PEA- Malfunction
- 515
- Total
- 515
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.