The following data is part of a premarket notification filed by Fudakang Industrial Co., Ltd with the FDA for Arm Blood Pressure Monitor, Wrist Blood Pressure Monitor.
| Device ID | K150430 |
| 510k Number | K150430 |
| Device Name: | Arm Blood Pressure Monitor, Wrist Blood Pressure Monitor |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | FUDAKANG INDUSTRIAL CO., LTD NO 8 YINGHE ROAD, YUANJIANGYUAN MANAGEMENT ZONE, CHANGPING TOWN Dongguan, CN 523560 |
| Contact | Bob Yu |
| Correspondent | Mr. Field Fu SHENZHEN JOYANTECH CONSULTING CO., LTD. 4TH FLOOR, JINHUI BUILDING NANHAI BLVD, NANSHAN DISTRICT Shenzhen, CN 518100 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-19 |
| Decision Date | 2015-04-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00867464000294 | K150430 | 000 |
| 00859020006000 | K150430 | 000 |
| 00852982006408 | K150430 | 000 |
| 00859020006321 | K150430 | 000 |
| 00894046001530 | K150430 | 000 |
| 05894046001511 | K150430 | 000 |
| 00894046001509 | K150430 | 000 |
| 00894046001417 | K150430 | 000 |
| 00894046001400 | K150430 | 000 |
| 00894046001233 | K150430 | 000 |
| 00852982006538 | K150430 | 000 |
| 16955647600087 | K150430 | 000 |
| 00694501169818 | K150430 | 000 |
| 00859020006116 | K150430 | 000 |
| 00859020006130 | K150430 | 000 |
| 00867464000287 | K150430 | 000 |
| 00867464000270 | K150430 | 000 |
| 00867464000263 | K150430 | 000 |
| 00867464000256 | K150430 | 000 |
| 00867464000249 | K150430 | 000 |
| 00867464000232 | K150430 | 000 |
| 00867464000225 | K150430 | 000 |
| 00867464000218 | K150430 | 000 |
| 00867464000201 | K150430 | 000 |
| 00859811007018 | K150430 | 000 |
| 00859020006260 | K150430 | 000 |
| 00859020006246 | K150430 | 000 |
| 00859020006369 | K150430 | 000 |