The following data is part of a premarket notification filed by Edan Instruments Inc with the FDA for Electrocardiograph.
| Device ID | K120188 |
| 510k Number | K120188 |
| Device Name: | ELECTROCARDIOGRAPH |
| Classification | Electrocardiograph |
| Applicant | EDAN INSTRUMENTS INC 3/F-B, NANSHAN MEDICAL EQUIPMENTS PARK Shenzhen, CN 518067 |
| Contact | Yue Qiuhong |
| Correspondent | Yue Qiuhong EDAN INSTRUMENTS INC 3/F-B, NANSHAN MEDICAL EQUIPMENTS PARK Shenzhen, CN 518067 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-23 |
| Decision Date | 2012-03-16 |
| Summary: | summary |