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 |