UltraviewSL
Multigas Module, 92518, Loaner Only
5manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (4), 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 |
Record
| Listed by | Spacelabs Healthcare (Washington), Inc |
|---|---|
| FDA product code | NHQ |
| Device type | Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1500 |
| 510(k) | K112173 |
| Record published | 2017-03-10 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number |
| Storage | Storage environment temperature -40 to 70 °C; Storage environment humidity 0 to 95 % RH |
| Distribution end date | 2017-03-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 92518 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) | GE Healthcare Finland OY | 3 |
| ISA™ AX+ | Masimo Corporation | 2 |
| NomoLine ISA™ AX+ | Masimo Corporation | 1 |
Recalls Naming This Product
1 recall names this product by its own identifier, 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 | 2014-06-18 | Class II | Process control | With this software version, the Minimum Alveolar Concentration (MAC) value displayed is extremely high (20.1) and physiologically invalid. | 8 units total (3 units in US) | 2014-12-08 |
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.