The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Electrocardiograph.
| Device ID | K102830 |
| 510k Number | K102830 |
| Device Name: | ELECTROCARDIOGRAPH |
| Classification | Electrocardiograph |
| Applicant | EDAN INSTRUMENTS, INC. 3/F-B NANSHAN MEDICAL EQUIPMEN PARK, NANHAI RD 1019# Shenzhen, CN 518067 |
| Contact | Yue Qiuhong (tracy) |
| Correspondent | Yue Qiuhong (tracy) EDAN INSTRUMENTS, INC. 3/F-B NANSHAN MEDICAL EQUIPMEN PARK, NANHAI RD 1019# 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 | 2010-09-29 |
| Decision Date | 2010-12-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815871020886 | K102830 | 000 |
| 00815871020770 | K102830 | 000 |
| 00815871020787 | K102830 | 000 |
| 00815871020794 | K102830 | 000 |
| 00815871020800 | K102830 | 000 |
| 00815871020817 | K102830 | 000 |
| 00815871020855 | K102830 | 000 |
| 00815871020862 | K102830 | 000 |
| 00815871020879 | K102830 | 000 |
| 00815871020763 | K102830 | 000 |