The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Fetal & Maternal Monitor, Models F6, F6 Express, F9, F9 Express.
| Device ID | K150901 |
| 510k Number | K150901 |
| Device Name: | Fetal & Maternal Monitor, Models F6, F6 Express, F9, F9 Express |
| Classification | System, Monitoring, Perinatal |
| Applicant | EDAN INSTRUMENTS, INC. 3/F - B, NANSHAN MEDICAL EQUIPMENTS PARK, NANHAI ROAD #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 | 2015-04-03 |
| Decision Date | 2015-07-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815871020282 | K150901 | 000 |
| 00815871020206 | K150901 | 000 |
| 00815871020213 | K150901 | 000 |
| 00815871020220 | K150901 | 000 |
| 00815871020237 | K150901 | 000 |
| 00815871020244 | K150901 | 000 |
| 00815871020251 | K150901 | 000 |
| 00815871020268 | K150901 | 000 |
| 00815871020275 | K150901 | 000 |
| 00815871020190 | K150901 | 000 |