The following data is part of a premarket notification filed by Contec Medical Systems Co., Ltd. with the FDA for Pulse Oximeter Cms50ew.
| Device ID | K141362 |
| 510k Number | K141362 |
| Device Name: | PULSE OXIMETER CMS50EW |
| Classification | Oximeter |
| Applicant | CONTEC MEDICAL SYSTEMS CO., LTD. P.O. BOX 120-119 Shangai, CN 200120 |
| Contact | Diana Hong |
| Correspondent | Diana Hong CONTEC MEDICAL SYSTEMS CO., LTD. P.O. BOX 120-119 Shangai, CN 200120 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-23 |
| Decision Date | 2015-04-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851908007062 | K141362 | 000 |
| 06945040104599 | K141362 | 000 |
| 06945040100812 | K141362 | 000 |