The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Revolution Ct, Revolution Ct Es, Revolution Apex, Revolution Ct With Apex Edition.
Device ID | K191777 |
510k Number | K191777 |
Device Name: | Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT With Apex Edition |
Classification | System, X-ray, Tomography, Computed |
Applicant | GE Medical Systems, LLC 3000 N. Grandview Blvd Waukesha, WI 53188 |
Contact | Laura Turner |
Correspondent | Laura Turner GE Medical Systems, LLC 3000 N. Grandview Blvd Waukesha, WI 53188 |
Product Code | JAK |
CFR Regulation Number | 892.1750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-07-02 |
Decision Date | 2019-07-26 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00840682146616 | K191777 | 000 |
00840682146319 | K191777 | 000 |