The following data is part of a premarket notification filed by Ningbo Albert Novosino Co.,ltd. with the FDA for Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff.
Device ID | K173044 |
510k Number | K173044 |
Device Name: | Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff |
Classification | Blood Pressure Cuff |
Applicant | Ningbo Albert Novosino Co.,Ltd. No.1 Xinheng 3 Road Cicheng Town Jiangbei District Ningbo, CN 315036 |
Contact | Ningbo Albert Novosino |
Correspondent | Doris Dong Shanghai CV Technology Co., Ltd. Room 903 Of Dongbao Building No. 19 Dongbao Road, Songjiang Area Shanghai, CN 201316 |
Product Code | DXQ |
CFR Regulation Number | 870.1120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-09-28 |
Decision Date | 2017-11-20 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B593CSST2635HP0 | K173044 | 000 |
06971919469025 | K173044 | 000 |