The following data is part of a premarket notification filed by Advanced Instrumentations, Inc. with the FDA for Fm-9000 Plus Fetal And Maternal Monitor.
| Device ID | K112317 |
| 510k Number | K112317 |
| Device Name: | FM-9000 PLUS FETAL AND MATERNAL MONITOR |
| Classification | System, Monitoring, Perinatal |
| Applicant | ADVANCED INSTRUMENTATIONS, INC. 601 WEST 20 ST Hialeah, FL 33010 |
| Contact | Jorge Millan |
| Correspondent | Jorge Millan ADVANCED INSTRUMENTATIONS, INC. 601 WEST 20 ST Hialeah, FL 33010 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-11 |
| Decision Date | 2011-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B510FM9000PLUSD1 | K112317 | 000 |
| B510FM9000PLUS1 | K112317 | 000 |