The following data is part of a premarket notification filed by Ge Medical Systems, L.l.c. with the FDA for Revolution Ct.
Device ID | K163213 |
510k Number | K163213 |
Device Name: | Revolution CT |
Classification | System, X-ray, Tomography, Computed |
Applicant | GE Medical Systems, L.L.C. 3000 N Grandview Blvd Waukesha, WI 53188 |
Contact | Helen Peng |
Correspondent | Helen Peng GE Medical Systems, L.L.C. 3000 N Grandview Blvd Waukesha, WI 53188 |
Product Code | JAK |
CFR Regulation Number | 892.1750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-11-16 |
Decision Date | 2016-12-16 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00840682143646 | K163213 | 000 |
00840682138796 | K163213 | 000 |
00840682123471 | K163213 | 000 |