The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Electrocardiograph.
Device ID | K171942 |
510k Number | K171942 |
Device Name: | Electrocardiograph |
Classification | Electrocardiograph |
Applicant | Edan Instruments, Inc. #15 Jinhui Road,Jinsha Community Kengzi Sub-District Pingshan District Shenzhen, CN 518122 |
Contact | Alice Yang |
Correspondent | Doug Worth Edan Medical 1200 Crossman Ave. Suite 200 Sunnyvale, CA 94089 |
Product Code | DPS |
CFR Regulation Number | 870.2340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-06-28 |
Decision Date | 2018-01-24 |
Summary: | summary |