The following data is part of a premarket notification filed by Ge Oec Medical Systems, Inc with the FDA for Oec(r) 9800, Oec(r) 9800 Plus.
Device ID | K111551 |
510k Number | K111551 |
Device Name: | OEC(R) 9800, OEC(R) 9800 PLUS |
Classification | Interventional Fluoroscopic X-ray System |
Applicant | GE OEC MEDICAL SYSTEMS, INC 384 WRIGHT BROTHERS DR. Salt Lake City, UT 84116 |
Contact | Gerald Buss |
Correspondent | Gerald Buss GE OEC MEDICAL SYSTEMS, INC 384 WRIGHT BROTHERS DR. Salt Lake City, UT 84116 |
Product Code | OWB |
Subsequent Product Code | JAA |
Subsequent Product Code | OXO |
CFR Regulation Number | 892.1650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-06-03 |
Decision Date | 2011-10-04 |
Summary: | summary |