The following data is part of a premarket notification filed by Shenzhen Carewell Electronics Co., Ltd with the FDA for Electrocardiograph.
| Device ID | K113485 |
| 510k Number | K113485 |
| Device Name: | ELECTROCARDIOGRAPH |
| Classification | Electrocardiograph |
| Applicant | SHENZHEN CAREWELL ELECTRONICS CO., LTD P.O. BOX 237-023 Shanghai, CN 200030 |
| Contact | Diana Hong |
| Correspondent | Diana Hong SHENZHEN CAREWELL ELECTRONICS CO., LTD P.O. BOX 237-023 Shanghai, CN 200030 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-23 |
| Decision Date | 2012-04-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06971049340706 | K113485 | 000 |
| 06971049340690 | K113485 | 000 |
| 06971049340683 | K113485 | 000 |
| 06971049340676 | K113485 | 000 |
| 06971049340669 | K113485 | 000 |
| 06971049340652 | K113485 | 000 |