Advanced Patient Monitor
Catalogue number PM-2000TM, listed by Advanced Instrumentations, Inc., United States, under Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration). 6 manufacturers in China are registered for this product code.
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 | Advanced Instrumentations, Inc., United States |
|---|---|
| FDA product code | CBQ |
| Device type | Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1500 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K132077 |
| Record published | 2020-04-16 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Distribution end date | 2028-04-15 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PM-2000TM | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Perma Pure | Perma Pure, LLC | 182 |
| Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | Philips Medizin Systeme Böblingen GmbH | 5 |
| Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | GE Healthcare Finland OY | 4 |
| Nafion Dryer | Perma Pure, LLC | 3 |
| Carescape | GE Medical Systems Information Technologies, Inc. | 1 |
| Pressure Monitoring Line with Nafion Dryer (BioMed Private Label) | Maxtec, LLC | 1 |
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.