The following data is part of a premarket notification filed by Edan Instruments Inc with the FDA for Central Monitoring System.
Device ID | K143695 |
510k Number | K143695 |
Device Name: | CENTRAL MONITORING SYSTEM |
Classification | System, Monitoring, Perinatal |
Applicant | EDAN INSTRUMENTS INC 3/F - B, NANSHAN MEDICAL EQUIPMENTS PARK NANHAI RD 1019# Shenzhen, CN 518067 |
Contact | Queena Chen |
Correspondent | Doug Worth EDAN MEDICAL 1200 CROSSMAN AVE, SUITE 200 Sunnyvale, CA 94089 |
Product Code | HGM |
CFR Regulation Number | 884.2740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-12-24 |
Decision Date | 2015-03-30 |
Summary: | summary |