FiO2
FiO2 Monitoring Sensor
4manufacturers in China registered for this device type
2catalogue numbers in this listing
1510(k) clearance
1recall
Who Else Makes It
Concentrated in Guangdong (3), Fujian (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
| Respironics Medical Products (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
Record
| Listed by | Resmed PTY Ltd., Australia |
|---|---|
| FDA product code | MNT |
| Device type | Sv70 Ventilator |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5895 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-26 |
| Record revised | 2023-07-31 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, serial number |
| Storage | Storage environment temperature -4 to 120 °F |
| Distribution end date | 2023-07-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 24955 | In distribution | |
| 24980 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| BiPAP A40 | Respironics Inc. | 102 |
| Philips | Respironics California, Inc. | 29 |
| DreamMapper | Respironics Inc. | 27 |
| Fisher & Paykel Healthcare | Fisher & Paykel Healthcare, Ltd. | 25 |
| BiPAP | Respironics Inc. | 11 |
| EncoreAnywhere | Respironics Inc. | 10 |
| Care Orchestrator | Respironics Inc. | 8 |
| A Series | Respironics Inc. | 7 |
| Nihon Kohden | Nihon Kohden Orangemed, LLC | 6 |
| Remote Alarm | Resmed PTY Ltd. | 5 |
| Stellar | Resmed PTY Ltd. | 5 |
| AF811 | Respironics Inc. | 4 |
Showing 12 of 53. All products under Sv70 Ventilator
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K974539 | 1998-08-06 |
Recalls
1 of these is Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2019-12-12 | Class I | Device Design | Combination of software and a component failure may cause audible alarms not to operate properly, the alarm buzzer not work, for ventilators that have a failed electronic component and, that are stored without AC power connected for more th | 69 |
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.