Advanced Fetal Monitor
Catalogue number FM-3000, listed by Advanced Instrumentations, Inc., United States, under Transducer, Pressure, Intrauterine. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
All of them in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Orantech Inc. | Shenzhen | Guangdong | Contract manufacturer | 40 |
Record
| Listed by | Advanced Instrumentations, Inc., United States |
|---|---|
| FDA product code | HFN |
| Device type | Transducer, Pressure, Intrauterine |
| Device class | Class 2 |
| Regulation | 21 CFR 884.2700 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K141194 |
| Record published | 2020-04-16 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Distribution end date | 2028-04-15 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FM-3000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Koala® Cables | Clinical Innovations, LLC | 9 |
| Intran | Utah Medical Products, Inc. | 8 |
| Koala® | Clinical Innovations, LLC | 2 |
| Transducer, Pressure, Intrauterine | Philips Medizin Systeme Böblingen GmbH | 1 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.