The following data is part of a premarket notification filed by Honsun (nantong) Co., Ltd with the FDA for Aneroid Sphygmomanometer With Stethoscope, Model Ld-100.
Device ID | K092245 |
510k Number | K092245 |
Device Name: | ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE, MODEL LD-100 |
Classification | Blood Pressure Cuff |
Applicant | HONSUN (NANTONG) CO., LTD ADD: NO8 TONGXING ROAD Jiangsu, CN |
Contact | David Zhang |
Correspondent | David Zhang HONSUN (NANTONG) CO., LTD ADD: NO8 TONGXING ROAD Jiangsu, CN |
Product Code | DXQ |
CFR Regulation Number | 870.1120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-07-28 |
Decision Date | 2009-10-28 |
Summary: | summary |