The following data is part of a premarket notification filed by Pentax Precision Instrument Corp. with the FDA for Fg-36ux, Ultrasound Upper Gi Fiberscope.
| Device ID | K961974 |
| 510k Number | K961974 |
| Device Name: | FG-36UX, ULTRASOUND UPPER GI FIBERSCOPE |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | PENTAX PRECISION INSTRUMENT CORP. 3117 COMMERCE PKWY. Miramar, FL 33025 |
| Contact | Paul Silva |
| Correspondent | Paul Silva PENTAX PRECISION INSTRUMENT CORP. 3117 COMMERCE PKWY. Miramar, FL 33025 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-20 |
| Decision Date | 1997-02-10 |
| Summary: | summary |