The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Se-601 Series Electrocardiograph.
| Device ID | K131503 |
| 510k Number | K131503 |
| Device Name: | SE-601 SERIES ELECTROCARDIOGRAPH |
| Classification | Electrocardiograph |
| Applicant | EDAN INSTRUMENTS, INC. NANHAI ROAD 1019# NANSHEN Shenzhen, Guangdong, CN 518067 |
| Contact | Cherry Sun |
| Correspondent | Cherry Sun EDAN INSTRUMENTS, INC. NANHAI ROAD 1019# NANSHEN Shenzhen, Guangdong, CN 518067 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-24 |
| Decision Date | 2014-02-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815871020848 | K131503 | 000 |
| 00815871020831 | K131503 | 000 |
| 00815871020824 | K131503 | 000 |