Battery Module
Catalogue number 6889000, listed by Maquet Critical Care AB, Sweden, under Sv70 Ventilator. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
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 | Maquet Critical Care AB, Sweden |
|---|---|
| FDA product code | MNT |
| Device type | Sv70 Ventilator |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5895 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K192604 |
| Record published | 2025-01-19 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6889000 | In distribution |
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 |
|---|---|
| K230173 | 2023-07-06 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Getinge Usa Sales Inc | 510(k) number | 2022-07-21 | Class II | Device Design | Device does not meet regulatory requirements of stability while stationary, which requires mechanical equipment, other than fixed mechanical equipment, that is intended to be used on the floor or on a table shall be permanently marked with | US 102 units; OUS 13750 units |
| Getinge Usa Sales Inc | 510(k) number | 2022-07-20 | Class I | Software in the Use Environment | Ventilators may generate a combination of alarms which may result in loss of communication, technical alarms being triggered, and loss of ventilation. If the device stops ventilating due to this issue, it may lead to hypoventilation and con | 37000 (11089 US) |
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.