The following data is part of a premarket notification filed by Pentax Precision Instrument Corp. with the FDA for Pentax Ultrasound Endoscope, Model Fg-32ua.
| Device ID | K904573 |
| 510k Number | K904573 |
| Device Name: | PENTAX ULTRASOUND ENDOSCOPE, MODEL FG-32UA |
| Classification | Endoscopic Ultrasound System, Gastroenterology-urology |
| Applicant | PENTAX PRECISION INSTRUMENT CORP. 30 RAMLAND RD. Orangeburg, NY 10962 |
| Contact | Lorraine Schwartz |
| Correspondent | Lorraine Schwartz PENTAX PRECISION INSTRUMENT CORP. 30 RAMLAND RD. Orangeburg, NY 10962 |
| Product Code | ODG |
| Subsequent Product Code | FDS |
| Subsequent Product Code | FET |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-09 |
| Decision Date | 1991-06-12 |