Assy Meridian Series
Assy Meridian Series Meridian CardiO2; Meridian CCM; Meridian CPX;
3manufacturers in China registered for this device type
1catalogue number
4510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Mehow Innovative Ltd | Shenzhen | Guangdong | Contract manufacturer | 2 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
Record
| Listed by | Medical Graphics Corp., United States |
|---|---|
| FDA product code | BZL |
| Device type | Computer, Oxygen-Uptake |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1730 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K061731 |
| Record published | 2026-06-10 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 790708-001 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MGC Diagnostics | Medical Graphics Corp. | 43 |
| Cosmed | C O S M E D SRL | 4 |
| Metaphor Flow Sensor | TreyMed, Inc. | 3 |
| Computer, Oxygen-Uptake | GE Healthcare Finland OY | 2 |
| MCG Diagnostics | Medical Graphics Corp. | 1 |
| Vista Mini-CPX Silver Edition | Vacumed | 1 |
| Maxii | AEI Technologies Inc. | 1 |
| MGC Diganostics | Medical Graphics Corp. | 1 |
| MAXIIa | AEI Technologies Inc. | 1 |
| Vista-MX Metabolic Measurement System | Vacumed | 1 |
| MGC Diagnsotics | Medical Graphics Corp. | 1 |
| MediPines Gas Exchange Monitor Starter Kit | Medipines Corporation | 1 |
Showing 12 of 22. All products under Computer, Oxygen-Uptake
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K070858 | 2007-04-16 |
| K061731 | 2006-09-06 |
| K912906 | 1992-02-04 |
| K820475 | 1982-03-23 |
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.