Patient Monitor
Oximeter
Shenzhen Creative Industry Co., Ltd.
The following data is part of a premarket notification filed by Shenzhen Creative Industry Co., Ltd. with the FDA for Patient Monitor.
Pre-market Notification Details
| Device ID | K192343 |
| 510k Number | K192343 |
| Device Name: | Patient Monitor |
| Classification | Oximeter |
| Applicant | Shenzhen Creative Industry Co., Ltd. Floor 5, BLD 9 Baiwangxin High-Tech Industrial Park Songbai Road, Xili Street Shenzhen, CN 518110 |
| Contact | Jia Wang |
| Correspondent | Charlie Mack IRC 2950 E Lindrick Drive Chandler, AZ 85249 |
| Product Code | DQA |
| Subsequent Product Code | CCK |
| Subsequent Product Code | DXN |
| Subsequent Product Code | FLL |
| Subsequent Product Code | MWI |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-28 |
| Decision Date | 2019-12-31 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06941900604292 | K192343 | 000 |
| 06941900604315 | K192343 | 000 |
Trademark Results [Patient Monitor]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PATIENT MONITOR 74564296 1942340 Live/Registered |
Brown, Frank L. 1994-08-22 |
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