The following data is part of a premarket notification filed by Pentax Of America, Inc. with the FDA for 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.
| Device ID | K190805 |
| 510k Number | K190805 |
| Device Name: | 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 |
| Classification | Endoscope, Accessories, Image Post-processing For Color Enhancement |
| Applicant | PENTAX Of America, Inc. 3 Paragon Drive Montvale, NJ 07645 -1782 |
| Contact | William Goeller |
| Correspondent | Beryl St. Jeanne NAMSA Inc. 400 Highway 169, Suite 500 Minneapolis, MN 55426 |
| Product Code | PEA |
| Subsequent Product Code | FDF |
| Subsequent Product Code | FDS |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-29 |
| Decision Date | 2019-12-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04961333248681 | K190805 | 000 |
| 04961333248513 | K190805 | 000 |
| 04961333248452 | K190805 | 000 |
| 04961333237579 | K190805 | 000 |
| 04961333237562 | K190805 | 000 |
| 04961333233557 | K190805 | 000 |
| 04961333175017 | K190805 | 000 |
| 04961333251650 | K190805 | 000 |