The following data is part of a premarket notification filed by Pentax Medical Company with the FDA for Pentax Video Upper G.i. Scopes (eg Family).
| Device ID | K131902 |
| 510k Number | K131902 |
| Device Name: | PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY) |
| Classification | Gastroscope And Accessories, Flexible/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 | FDS |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-25 |
| Decision Date | 2014-04-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04961333243372 | K131902 | 000 |
| 04961333248292 | K131902 | 000 |
| 04961333070435 | K131902 | 000 |
| 04961333075331 | K131902 | 000 |
| 04961333077748 | K131902 | 000 |
| 04961333084050 | K131902 | 000 |
| 04961333085132 | K131902 | 000 |
| 04961333129454 | K131902 | 000 |
| 04961333146253 | K131902 | 000 |
| 04961333248155 | K131902 | 000 |
| 04961333084029 | K131902 | 000 |
| 04961333254835 | K131902 | 000 |
| 04961333254842 | K131902 | 000 |
| 04961333254859 | K131902 | 000 |
| 04961333254873 | K131902 | 000 |
| 04961333254880 | K131902 | 000 |
| 04961333070466 | K131902 | 000 |
| 04961333071043 | K131902 | 000 |
| 04961333077731 | K131902 | 000 |
| 04961333223022 | K131902 | 000 |
| 04961333223909 | K131902 | 000 |
| 04961333232468 | K131902 | 000 |
| 04961333232475 | K131902 | 000 |
| 04961333232482 | K131902 | 000 |
| 04961333232512 | K131902 | 000 |
| 04961333232529 | K131902 | 000 |
| 04961333232536 | K131902 | 000 |
| 04961333232543 | K131902 | 000 |
| 04961333232574 | K131902 | 000 |
| 04961333232451 | K131902 | 000 |
| 04961333232444 | K131902 | 000 |
| 04961333225026 | K131902 | 000 |
| 04961333225651 | K131902 | 000 |
| 04961333225712 | K131902 | 000 |
| 04961333225743 | K131902 | 000 |
| 04961333227044 | K131902 | 000 |
| 04961333227099 | K131902 | 000 |
| 04961333228478 | K131902 | 000 |
| 04961333228492 | K131902 | 000 |
| 04961333254828 | K131902 | 000 |