TrueOne 2400
The TrueOne® 2400 is a compact, integrated metabolic measurement system for cardiopulmonary stress testing, indirect calorimetry, and maximal O2 consumption measurement.
1manufacturer
1catalogue number
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
Record
| Listed by | Parvomedics, Incorporated |
|---|---|
| FDA product code | BZC |
| Device type | Calculator, Pulmonary Function Data |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1880 |
| 510(k) | K941843 |
| Record published | 2018-09-06 |
| Record revised | 2022-03-08 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MMS-2400 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Jaeger | Jaeger Medical GmbH | 227 |
| Vyaire | Jaeger Medical GmbH | 120 |
| Vyntus | Jaeger Medical GmbH | 14 |
| Innocor | Innovision Medical Technologies, LLC | 6 |
| Vyntus | Vyaire Medical, Inc. | 3 |
| Cosmed | C O S M E D SRL | 3 |
| APS-Pro SA | Jaeger Medical GmbH | 3 |
| MGC Diagnostics | Medical Graphics Corp. | 2 |
| TransAir3 | Medi Soft SA | 1 |
| MasterScreen PFT | Jaeger Medical GmbH | 1 |
| Respiratory Mechanics Sensor → Neonatal | Draeger Medical Systems, Inc. | 1 |
| SentrySuite Software | Jaeger Medical GmbH | 1 |
Showing 12 of 19. All products under Calculator, Pulmonary Function Data
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.