The following data is part of a premarket notification filed by Orich Medical Equipment (tianjin Co., Ltd. with the FDA for Radiographic X-ray System.
Device ID | K120034 |
510k Number | K120034 |
Device Name: | RADIOGRAPHIC X-RAY SYSTEM |
Classification | System, X-ray, Stationary |
Applicant | ORICH MEDICAL EQUIPMENT (TIANJIN CO., LTD. 6840 SW 45TH LN #5 Miami, FL 33155 |
Contact | Jun Peng |
Correspondent | Jun Peng ORICH MEDICAL EQUIPMENT (TIANJIN CO., LTD. 6840 SW 45TH LN #5 Miami, FL 33155 |
Product Code | KPR |
CFR Regulation Number | 892.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-01-04 |
Decision Date | 2012-04-17 |
Summary: | summary |