The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Central Monitoring System.
| Device ID | K100358 |
| 510k Number | K100358 |
| Device Name: | CENTRAL MONITORING SYSTEM |
| Classification | System, Monitoring, Perinatal |
| Applicant | EDAN INSTRUMENTS, INC. 1 ODELL PLAZA Yonkers, NY 10701 |
| Contact | William Stern |
| Correspondent | William Stern EDAN INSTRUMENTS, INC. 1 ODELL PLAZA Yonkers, NY 10701 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-12 |
| Decision Date | 2011-01-06 |
| Summary: | summary |