Voyager Infant Transport Incubator
Voyager Infant Transport Incubator, with Optional PulseOx
1manufacturer
2catalogue numbers in this listing
7510(k) clearances naming this product code
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) | K022876 |
| Record published | 2023-06-20 |
| 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 |
|---|---|---|
| Voyager | In distribution | |
| Voyager | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 185A+ Infant 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 |
| Isolette TI500 Transport Incubator | Draeger Medical Systems, Inc. | 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.