The following data is part of a premarket notification filed by Fujifilm Medical System U.s.a., Inc. with the FDA for Fujifilm Ultrasonic Processors Su-1 Platinum And Su-1.
Device ID | K153206 |
510k Number | K153206 |
Device Name: | Fujifilm Ultrasonic Processors SU-1 PLATINUM And SU-1 |
Classification | Gastroscope And Accessories, Flexible/rigid |
Applicant | FUJIFILM MEDICAL SYSTEM U.S.A., INC. 10 HIGH POINT DRIVE Wayne, NJ 07470 |
Contact | Shraddha More |
Correspondent | Shraddha More FUJIFILM MEDICAL SYSTEM U.S.A., INC. 10 HIGH POINT DRIVE Wayne, NJ 07470 |
Product Code | FDS |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-11-05 |
Decision Date | 2016-03-03 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04547410332377 | K153206 | 000 |
04547410332360 | K153206 | 000 |
04547410332353 | K153206 | 000 |
04547410332346 | K153206 | 000 |