The following data is part of a premarket notification filed by Shenzhen Creative Industry Co., Ltd. with the FDA for All-in-one Health Monitor, Pc-303.
| Device ID | K170047 |
| 510k Number | K170047 |
| Device Name: | All-in-One Health Monitor, PC-303 |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | Shenzhen Creative Industry Co., Ltd. 2/F, Block 3, Nanyou Tian'an Industry Town Shenzhen, CN 518054 |
| Contact | Jia Wang |
| Correspondent | Charles Mack IRC, LLC 7808 Rush Creek Drive Pasco, WA 99301 |
| Product Code | MWI |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DSH |
| Subsequent Product Code | DXN |
| Subsequent Product Code | FLL |
| Subsequent Product Code | NBW |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-05 |
| Decision Date | 2017-09-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06941900603523 | K170047 | 000 |