A750i Infant Incubator
The A750i is a neonatal transport incubator used by trained medical technical personnel during ground or air transport. It circulates warmed air at an operator-selected, controlled…
The A750i is a neonatal transport incubator used by trained medical technical personnel during ground or air transport. It circulates warmed air at an operator-selected, controlled temperature through a transparent chamber containing the infant to maintain a thermally regulated environment.
The incubator can operate from an external power source or an internal rechargeable battery. Its structure also accommodates separate equipment for neonatal life support and patient monitoring during transport.
Listed Item
A750i Infant Transport Incubator, with Optional PulseOx
Monitoring Options
The PulseOx configuration offers integrated pulse oximetry and oxygen monitoring on the display panel. Pulse oximetry versions use Nellcor or Masimo technology with the corresponding patient cabling. Auxiliary airway management and vital signs equipment is not standard equipment.
Who Else Makes It
Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol (Changzhou) Connector Systems Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 4 |
Record
| Listed by | International Biomedical, Ltd., United States |
|---|---|
| FDA product code | FPL |
| Device type | Incubator, Neonatal Transport |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5410 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K103525 |
| Record published | 2016-09-27 |
| Record revised | 2024-09-19 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A750i | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 185A+ Infant Incubator | International Biomedical, Ltd. | 2 |
| Voyager Infant Transport Incubator | International Biomedical, Ltd. | 2 |
| NxtGen Infant Transport Incubator | International Biomedical, Ltd. | 2 |
| Reusable Skin Temperature Probes | Flexicare Medical Ltd. | 2 |
| LMT nomag® IC 1.5 | LMT Medical Systems Gmbh | 2 |
| Aviator Transport Incubator | International Biomedical, Ltd. | 2 |
| LMT nomag® IC 3.0 | LMT Medical Systems Gmbh | 2 |
| Disposable Skin Temperature Probes | Flexicare Medical Ltd. | 2 |
| Filter Element E(10 pcs/pkg) For V-808/V-850TR/V-80TR | Atom Medical Corporation | 1 |
| Advanced Transport Incubator | Advanced Instrumentations, Inc. | 1 |
| V-808 Main Unit Only(120 V) | Atom Medical Corporation | 1 |
| Oxygen Sensor For V-808 | Atom Medical Corporation | 1 |
Showing 12 of 18. All products under Incubator, Neonatal Transport
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K220742 | 2022-07-15 |
| K103523 | 2011-05-11 |
| K103525 | 2011-05-11 |
| K103524 | 2011-04-15 |
| K103527 | 2011-04-15 |
| K081399 | 2008-06-06 |
| K022876 | 2002-09-11 |
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.