The following data is part of a premarket notification filed by Pentax Medical Company with the FDA for Pentax Video Bronchoscopes (eb Family).
| Device ID | K131028 |
| 510k Number | K131028 |
| Device Name: | PENTAX VIDEO BRONCHOSCOPES (EB FAMILY) |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | PENTAX MEDICAL COMPANY 3 PARAGON DRIVE Montvale, NJ 07645 |
| Contact | Krishna Govindarajan |
| Correspondent | Krishna Govindarajan PENTAX MEDICAL COMPANY 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 | 2013-04-12 |
| Decision Date | 2014-04-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04961333243334 | K131028 | 000 |
| 04961333227198 | K131028 | 000 |
| 04961333226863 | K131028 | 000 |
| 04961333226818 | K131028 | 000 |
| 04961333223206 | K131028 | 000 |
| 04961333086399 | K131028 | 000 |
| 04961333085088 | K131028 | 000 |
| 04961333070657 | K131028 | 000 |
| 04961333070640 | K131028 | 000 |
| 04961333070633 | K131028 | 000 |
| 04961333063710 | K131028 | 000 |
| 04961333086412 | K131028 | 000 |
| 04961333227273 | K131028 | 000 |
| 04961333228102 | K131028 | 000 |
| 04961333228133 | K131028 | 000 |
| 04961333243327 | K131028 | 000 |
| 04961333243297 | K131028 | 000 |
| 04961333242832 | K131028 | 000 |
| 04961333242825 | K131028 | 000 |
| 04961333232222 | K131028 | 000 |
| 04961333232215 | K131028 | 000 |
| 04961333232192 | K131028 | 000 |
| 04961333232185 | K131028 | 000 |
| 04961333232178 | K131028 | 000 |
| 04961333232161 | K131028 | 000 |
| 04961333232154 | K131028 | 000 |
| 04961333254996 | K131028 | 000 |