The following data is part of a premarket notification filed by Platinum Team Co., Ltd with the FDA for Ezsleep Sleep Quality Recorder.
| Device ID | K112573 |
| 510k Number | K112573 |
| Device Name: | EZSLEEP SLEEP QUALITY RECORDER |
| Classification | Electrocardiograph, Ambulatory (without Analysis) |
| Applicant | PLATINUM TEAM CO., LTD 396 DAYE ROAD Taipai, TW 11268 |
| Contact | James Ho |
| Correspondent | James Ho PLATINUM TEAM CO., LTD 396 DAYE ROAD Taipai, TW 11268 |
| Product Code | MWJ |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-06 |
| Decision Date | 2012-03-22 |
| Summary: | summary |