The following data is part of a premarket notification filed by Grandway Technology (shenzhen) Limited with the FDA for Digital Automatic Wrist Blood Pressure Monitor Swbpm22 Series.
| Device ID | K142088 |
| 510k Number | K142088 |
| Device Name: | DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR SWBPM22 SERIES |
| 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 | 2014-08-01 |
| Decision Date | 2014-10-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10845717006924 | K142088 | 000 |
| 00845717006484 | K142088 | 000 |