Spacelabs Healthcare
Fetal Intra-Partum Monitor
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 | CBS |
| Device type | Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1620 |
| Premarket notification | Exempt |
| Record published | 2017-04-13 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Storage | Storage environment humidity 10 to 90 % RH; Storage environment temperature -20 to 50 °C |
| Distribution end date | 2017-04-19 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 94830 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | Philips Medizin Systeme Böblingen GmbH | 3 |
| Irma™ AX+ | Masimo Corporation | 3 |
| Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | GE Healthcare Finland OY | 2 |
| Waveline Pro+ | Avante | 2 |
| Irma Airway Adapter | Masimo Corporation | 2 |
| Carescape Canvas D19 | GE Healthcare Finland OY | 1 |
| IntelliVue G7m Gas Analyzer Module | Philips Medizin Systeme Böblingen GmbH | 1 |
| Waveline Touch+ | Avante | 1 |
| Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | GE Medical Systems Information Technologies, Inc. | 1 |
| Waveline EZ-MAX | Avante | 1 |
| Carescape RAD | GE Healthcare Finland OY | 1 |
| Water Trap | Philips Medizin Systeme Böblingen GmbH | 1 |
Showing 12 of 13. All products under Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
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.