The following data is part of a premarket notification filed by Edan Instruments Inc with the FDA for Mfm-cms Central Monitoring System.
| Device ID | K120727 |
| 510k Number | K120727 |
| Device Name: | MFM-CMS CENTRAL MONITORING SYSTEM |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | EDAN INSTRUMENTS INC 3/F-B, NANSHAN MEDICAL EQUIPMENTS PARK Shenzhen, CN 518067 |
| Contact | Randy Jiang |
| Correspondent | Randy Jiang EDAN INSTRUMENTS INC 3/F-B, NANSHAN MEDICAL EQUIPMENTS PARK Shenzhen, CN 518067 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-09 |
| Decision Date | 2013-06-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944413800229 | K120727 | 000 |