The following data is part of a premarket notification filed by Shanghai Chenguang Medical Technologies Co, Ltd with the FDA for Carotid Coil 5000004901.
Device ID | K092962 |
510k Number | K092962 |
Device Name: | CAROTID COIL 5000004901 |
Classification | Coil, Magnetic Resonance, Specialty |
Applicant | SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD BLDG 8, LANE 1199, JIDI ROAD Shanghai, CN 201107 |
Contact | Jie Huang |
Correspondent | Casey Conry UNDERWRITERS LABORATORIES, INC. 1285 WALT WHITMAN RD. Melville, NY 11747 |
Product Code | MOS |
CFR Regulation Number | 892.1000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2009-09-25 |
Decision Date | 2009-10-09 |
Summary: | summary |