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 |