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 |