The following data is part of a premarket notification filed by Shanghai Hulu Devices Co., Ltd with the FDA for Accutension Smartphone Auscultatory Blood.
| Device ID | K180335 |
| 510k Number | K180335 |
| Device Name: | Accutension Smartphone Auscultatory Blood |
| Classification | Blood Pressure Cuff |
| Applicant | Shanghai Hulu Devices Co., Ltd No. 509 Caobao Road, Room 101-2 Bld 9, Xuhui District Shanghai, CN |
| Contact | Junfeng Zhao |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2018-02-06 |
| Decision Date | 2018-03-08 |
| Summary: | summary |