The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Gf-um130 Ultrasound Gastrovideoscope, Its Associated Accessories And Ancillary Equipment.
| Device ID | K971660 |
| 510k Number | K971660 |
| Device Name: | OLYMPUS GF-UM130 ULTRASOUND GASTROVIDEOSCOPE, ITS ASSOCIATED ACCESSORIES AND ANCILLARY EQUIPMENT |
| Classification | Gastroscope And Accessories, Flexible/rigid |
| Applicant | OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Contact | Subhash R Patel |
| Correspondent | Subhash R Patel 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 | 1997-05-06 |
| Decision Date | 1997-07-25 |
| Summary: | summary |