The following data is part of a premarket notification filed by Honsun(nantong)co.,ltd with the FDA for Aneroid Sphygmomanometer With Stethoscope, Aneroid Sphygmomanometer.
Device ID | K192500 |
510k Number | K192500 |
Device Name: | Aneroid Sphygmomanometer With Stethoscope, Aneroid Sphygmomanometer |
Classification | Blood Pressure Cuff |
Applicant | Honsun(Nantong)Co.,Ltd No.8, Tongxing Road, Nantong Economic & Technology Development Area Nantong, CN 226009 |
Contact | Iris Du |
Correspondent | Iris Du Honsun(Nantong)Co.,Ltd No.8, Tongxing Road, Nantong Economic & Technology Development Area Nantong, CN 226009 |
Product Code | DXQ |
CFR Regulation Number | 870.1120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-09-12 |
Decision Date | 2020-04-06 |