The following data is part of a premarket notification filed by Contec Medical System Co., Ltd. with the FDA for Fingertip Pulse Oximeter, Models Cms-50d, Cms-50l, Cms-50dl.
| Device ID | K082641 |
| 510k Number | K082641 |
| Device Name: | FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-11 |
| Decision Date | 2008-11-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817746020151 | K082641 | 000 |
| 00850253007116 | K082641 | 000 |
| 00817698020544 | K082641 | 000 |
| 90817698020592 | K082641 | 000 |
| D040200121501 | K082641 | 000 |
| D040200121301 | K082641 | 000 |
| D040200121201 | K082641 | 000 |
| 00847713000589 | K082641 | 000 |