The following data is part of a premarket notification filed by Shenzhen Creative Industry Co., Ltd with the FDA for Vital Signs Monitor.
| Device ID | K093016 |
| 510k Number | K093016 |
| Device Name: | VITAL SIGNS MONITOR |
| Classification | Oximeter |
| Applicant | SHENZHEN CREATIVE INDUSTRY CO., LTD 77325 JOYCE WAY Echo, OR 97826 |
| Contact | Charlie Mack |
| Correspondent | Charlie Mack SHENZHEN CREATIVE INDUSTRY CO., LTD 77325 JOYCE WAY Echo, OR 97826 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-29 |
| Decision Date | 2010-03-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817698020131 | K093016 | 000 |
| 00817698020032 | K093016 | 000 |