The following data is part of a premarket notification filed by Advanced Instrumentations, Inc. with the FDA for Fm-3000 Fetal Monitor.
| Device ID | K141194 |
| 510k Number | K141194 |
| Device Name: | FM-3000 FETAL MONITOR |
| Classification | System, Monitoring, Perinatal |
| Applicant | ADVANCED INSTRUMENTATIONS, INC. 601 WEST 20 STREET Hialeah, FL 33010 |
| Contact | Jorge Millan |
| Correspondent | Jorge Millan ADVANCED INSTRUMENTATIONS, INC. 601 WEST 20 STREET Hialeah, FL 33010 |
| Product Code | HGM |
| Subsequent Product Code | HFN |
| Subsequent Product Code | HGP |
| Subsequent Product Code | HGS |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-08 |
| Decision Date | 2014-11-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B510FM30001 | K141194 | 000 |