The following data is part of a premarket notification filed by Shenzhen Combei Technology Co., Ltd with the FDA for Arm Type Blood Pressure Monitor, Digital Blood Pressure Monitor-automatic Upper Arm Style.
| Device ID | K181104 |
| 510k Number | K181104 |
| Device Name: | Arm Type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Shenzhen Combei Technology CO., LTD 11-5B No.105, Huanguan South Road, Dahe Community, Guanlan Guanlan, Shenzhen, CN 518110 |
| Contact | Kevin Fong |
| Correspondent | Field Fu Shenzhen Joyantech Consulting Co., Ltd 1122#, International Mayor Communication Center, Baishizhong Road 55# Nanshan District, Shenzhen, CN 518000 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-26 |
| Decision Date | 2018-08-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06948158404469 | K181104 | 000 |
| 06948158404452 | K181104 | 000 |
| 08906101765676 | K181104 | 000 |
| 06948158401499 | K181104 | 000 |
| 00616784709635 | K181104 | 000 |