The following data is part of a premarket notification filed by Grandway Technology (shenzhen) Limited with the FDA for Digital Automatic Blood Pressure Monitor Bpm25 & Bpm26 Series [model No.: Md25x0/ Md26x0].
| Device ID | K150373 |
| 510k Number | K150373 |
| Device Name: | Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series [Model No.: MD25x0/ MD26x0] |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED BLOCK 6 AND 7, ZHU KENG INDUSTRIAL ZONE, PING SHAN, LONG GANG DISTRICT, SHENZHEN, Guang Dong, CN |
| Contact | Patrick Chow |
| Correspondent | Patrick Chow GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED BLOCK 6 AND 7, ZHU KENG INDUSTRIAL ZONE, PING SHAN, LONG GANG DISTRICT, SHENZHEN, Guang Dong, CN |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-13 |
| Decision Date | 2015-06-11 |
| Summary: | summary |