UltraviewSL
Uvsl Multigas Analyzer, Dual Agent ID, Loaner
6manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (5), Jiangsu (1). 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 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Guangdong Biolight Meditech Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 19 |
Record
| Listed by | Spacelabs Healthcare (Washington), Inc |
|---|---|
| FDA product code | CBR |
| Device type | Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1700 |
| 510(k) | K053599 |
| Record published | 2017-03-10 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Storage | Storage environment humidity 10 to 95 % RH; Storage environment temperature -20 to 70 °C |
| Distribution end date | 2017-03-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 91518 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | GE Healthcare Finland OY | 4 |
| Trulink | Spacelabs Healthcare (Washington), Inc | 3 |
| Spacelabs Healthcare | Spacelabs Healthcare (Washington), Inc | 1 |
| 19″display(adapter/2.3M | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 1 |
| 22″display(adapter/2.3M | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 1 |
| AG Module(O2/package/accessory) | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 1 |
| 19″display(adapter/10M/VP1) | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 1 |
| Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | GE Medical Systems Information Technologies, Inc. | 1 |
| Spacelabs | Spacelabs Healthcare (Washington), Inc | 1 |
| Carescape B850 | GE Healthcare Finland OY | 1 |
| SMR integrated mount accessory Kit | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 1 |
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 | Closed |
|---|---|---|---|---|---|---|---|
| Spacelabs Healthcare Ltd. | 510(k) number | 2011-06-08 | Not classified | Software design | Spacelabs received a report of the Model 91518 Multigas Analyzer trending low levels of an anesthetic agent that is not present during a particular case. The error is limited to only the trend table data. | 481 units worldwide (333 units internationally and 148 units | 2011-09-21 |
| Spacelabs Healthcare Ltd. | 510(k) number | 2007-10-08 | Not classified | Software design | Inaccurate partial pressure readings; readings are not compensated for ambient pressure in mmHg or kPa. | 722 devices | 2011-04-12 |
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.