The following data is part of a premarket notification filed by Contec Medical System Co., Ltd. with the FDA for Fingertip Pulse Oximeter, Model Cms-50c.
| Device ID | K073454 |
| 510k Number | K073454 |
| Device Name: | FINGERTIP PULSE OXIMETER, MODEL CMS-50C |
| Classification | Oximeter |
| Applicant | CONTEC MEDICAL SYSTEM CO., LTD. SUITE 8D , ZHONGXIN ZHONGSHAN MANSION, NO. 19, LANE 999, Zhong Shan, Shanghai, CN 20030 |
| Contact | Diana Hong |
| Correspondent | Diana Hong CONTEC MEDICAL SYSTEM CO., LTD. SUITE 8D , ZHONGXIN ZHONGSHAN MANSION, NO. 19, LANE 999, Zhong Shan, Shanghai, CN 20030 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-10 |
| Decision Date | 2008-05-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10846036007692 | K073454 | 000 |
| 06945040100614 | K073454 | 000 |
| 06945040100102 | K073454 | 000 |