AIV
Fetal Transducer Philips Ultrasound
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 | American IV Products, Inc. |
|---|---|
| FDA product code | HGL |
| Device type | Transducer, Ultrasonic, Obstetric |
| Device class | Class 2 |
| Regulation | 21 CFR 884.2960 |
| 510(k) | K040392 |
| Record published | 2016-09-24 |
| Record revised | 2018-07-06 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature 14 to 140 °F |
| Sizes | Length 122.75 in; height 0.8 in; outer diameter 2.75 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FM10835 | Length 122.75 in | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ultrasound Transducer | Edan Instruments, Inc. | 4 |
| Dopplex | Huntleigh Healthcare Ltd. | 3 |
| US Transducer | Edan Instruments, Inc. | 3 |
| Fetal & Maternal Module | Edan Instruments, Inc. | 2 |
| Toco Transducer | Edan Instruments, Inc. | 2 |
| Fetal monitor | Edan Instruments, Inc. | 2 |
| 2.20MHZ OB Probe 641-A | Parks Medical Electronics, Inc. | 1 |
| 2.75 MHZ OB Probe | Parks Medical Electronics, Inc. | 1 |
| Transducer, Ultrasonic, Obstetric | Edan Instruments, Inc. | 1 |
| 2.00MHZ OB Probe 641 | Parks Medical Electronics, Inc. | 1 |
| 2.10MHZ OB Probe 641 | Parks Medical Electronics, Inc. | 1 |
| 2.10MHZ OB Probe 641-A | Parks Medical Electronics, Inc. | 1 |
Showing 12 of 27. All products under Transducer, Ultrasonic, Obstetric
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P800016 | 1986-01-08 | TENNANT(TM) & KELMAN(TM) TYPE II | Bausch & Lomb Incorporated |
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.