The following data is part of a premarket notification filed by Contec Medical System Co., Ltd. with the FDA for Pulse Oximeter, Models Cms50e, Cms50f, Cms60c, Cms60d.
| Device ID | K090671 |
| 510k Number | K090671 |
| Device Name: | PULSE OXIMETER, MODELS CMS50E, CMS50F, CMS60C, CMS60D |
| 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 | 2009-03-13 |
| Decision Date | 2009-06-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10822383549450 | K090671 | 000 |
| 06945040100126 | K090671 | 000 |
| 06945040100218 | K090671 | 000 |
| 06945040100225 | K090671 | 000 |
| 06945040100232 | K090671 | 000 |
| 06945040100676 | K090671 | 000 |
| 06945040104575 | K090671 | 000 |
| 00851908007031 | K090671 | 000 |
| 00851908007055 | K090671 | 000 |
| 00851908007079 | K090671 | 000 |
| 00817698020018 | K090671 | 000 |
| 00817698020056 | K090671 | 000 |
| 00817698020063 | K090671 | 000 |
| 00817698020070 | K090671 | 000 |
| 10822383259755 | K090671 | 000 |
| 10822383549443 | K090671 | 000 |
| 00851457007278 | K090671 | 000 |