The following data is part of a premarket notification filed by Shenzhen Creative Industry Co., Ltd with the FDA for Pc-60nw Fingertip Oximeter.
| Device ID | K120502 |
| 510k Number | K120502 |
| Device Name: | PC-60NW FINGERTIP OXIMETER |
| Classification | Oximeter |
| Applicant | SHENZHEN CREATIVE INDUSTRY CO., LTD 77325 JOYCE WAY Echo, OR 97826 |
| Contact | Charles Mack |
| Correspondent | Charles 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 | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-21 |
| Decision Date | 2012-12-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| BB4B963PO401W1 | K120502 | 000 |
| 06941900603240 | K120502 | 000 |
| 06941900604414 | K120502 | 000 |