The following data is part of a premarket notification filed by Fujinon, Inc. with the FDA for Endoscopically Deliveralbe Ultrasound Point Porbe System (endoscopy).
| Device ID | K971528 |
| 510k Number | K971528 |
| Device Name: | ENDOSCOPICALLY DELIVERALBE ULTRASOUND POINT PORBE SYSTEM (ENDOSCOPY) |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | FUJINON, INC. 399 PARK AVE. New York, NY 10022 -4689 |
| Contact | Gary A Adler |
| Correspondent | Gary A Adler FUJINON, INC. 399 PARK AVE. New York, NY 10022 -4689 |
| Product Code | IYO |
| Subsequent Product Code | ITX |
| Subsequent Product Code | ODG |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-28 |
| Decision Date | 1997-12-12 |