The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Ultrasound Gastroscope Gf Type Um30p.
| Device ID | K963023 |
| 510k Number | K963023 |
| Device Name: | ULTRASOUND GASTROSCOPE GF TYPE UM30P |
| Classification | Gastroscope And Accessories, Flexible/rigid |
| Applicant | OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Contact | Barry E Snads |
| Correspondent | Barry E Snads OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Product Code | FDS |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-05 |
| Decision Date | 1997-02-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170355714 | K963023 | 000 |