The following data is part of a premarket notification filed by Pentax Of America, Inc. with the FDA for Pentax Medical Ekp-i5010 Video Processor With Eb Family.
| Device ID | K143727 |
| 510k Number | K143727 |
| Device Name: | PENTAX Medical EKP-i5010 Video Processor With EB Family |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | PENTAX OF AMERICA, INC. 3 PARAGON DRIVE Montvale, NJ 07645 |
| Contact | Krishna Govindarajan |
| Correspondent | Krishna Govindarajan PENTAX OF AMERICA, INC. 3 PARAGON DRIVE Montvale, NJ 07645 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-29 |
| Decision Date | 2015-10-29 |
| Summary: | summary |