The following data is part of a premarket notification filed by Pentax Precision Instrument Corp. with the FDA for Eg-3830ut, Video Ultrasound Gastroscope.
| Device ID | K023401 |
| 510k Number | K023401 |
| Device Name: | EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE |
| Classification | Endoscopic Ultrasound System, Gastroenterology-urology |
| Applicant | PENTAX PRECISION INSTRUMENT CORP. 30 RAMLAND RD. Orangeburg, NY 10962 |
| Contact | Paul Silva |
| Correspondent | Paul Silva PENTAX PRECISION INSTRUMENT CORP. 30 RAMLAND RD. Orangeburg, NY 10962 |
| Product Code | ODG |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-09 |
| Decision Date | 2003-02-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04961333171507 | K023401 | 000 |
| 04961333085002 | K023401 | 000 |
| 04961333072989 | K023401 | 000 |
| 04961333071579 | K023401 | 000 |
| 04961333063932 | K023401 | 000 |