The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Revolution Ct.
Device ID | K133705 |
510k Number | K133705 |
Device Name: | REVOLUTION CT |
Classification | System, X-ray, Tomography, Computed |
Applicant | GE MEDICAL SYSTEMS, LLC 3000 N GRANDVIEW BLVD. Waukesha, WI 53188 |
Contact | Helen Peng |
Correspondent | Helen Peng GE MEDICAL SYSTEMS, LLC 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 | 2013-12-03 |
Decision Date | 2014-04-11 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00840682140713 | K133705 | 000 |