The following data is part of a premarket notification filed by Pentax Precision Instrument Corp. with the FDA for Fg-36ux Fiber Ultrasound Gastroscope.
| Device ID | K041396 |
| 510k Number | K041396 |
| Device Name: | FG-36UX FIBER ULTRASOUND GASTROSCOPE |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | PENTAX PRECISION INSTRUMENT CORP. 30 RAMLAND RD. Orangeburg, NY 10962 |
| Contact | Paul Silva |
| Correspondent | Matthias Heinze TUV RHEINLAND OF NORTH AMERICA, INC. 1279 QUARRY LANE, SUITE A Pleasanton, CA 94566 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-05-26 |
| Decision Date | 2004-06-09 |
| Summary: | summary |