The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Pc Ecg.
| Device ID | K102854 |
| 510k Number | K102854 |
| Device Name: | PC ECG |
| Classification | Electrocardiograph |
| Applicant | EDAN INSTRUMENTS, INC. NANHAI ROAD 1019# NANSHEN Shenzhen, Guangdong, CN 518067 |
| Contact | Yue Qiuhong (tracy) |
| Correspondent | Yue Qiuhong (tracy) EDAN INSTRUMENTS, INC. NANHAI ROAD 1019# NANSHEN Shenzhen, Guangdong, 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 | 2010-12-03 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PC ECG 78322450 not registered Dead/Abandoned |
BTS Holdings 2003-11-03 |