MGC Diagnostics
Ultima System PFX CardiO2 - 230V UPS
3manufacturers in China registered for this device type
43catalogue numbers in this listing
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 | 2019-02-22 |
| Record revised | 2021-08-10 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2019-02-23 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 800830-001 | In distribution | |
| 800820-011 | In distribution | |
| 800820-021 | In distribution | |
| 800860-031 | In distribution | |
| 800810-001 | In distribution | |
| 800850-001 | In distribution | |
| 800830-011 | In distribution | |
| 800820-001 | In distribution | |
| 800830-031 | In distribution | |
| 800840-021 | In distribution | |
| 700023-905 | In distribution | |
| 800840-031 | In distribution | |
| 800820-031 | In distribution | |
| 800860-001 | In distribution | |
| 800840-001 | In distribution | |
| 800840-031 | In distribution | |
| 800840-001 | In distribution | |
| 800840-011 | In distribution | |
| 800810-021 | In distribution | |
| 800860-011 | In distribution | |
| 800850-001 | In distribution | |
| 800840-021 | In distribution | |
| 800860-021 | In distribution | |
| 800830-021 | In distribution | |
| 800810-011 | In distribution | |
| 800840-011 | In distribution | |
| 800830-031 | Withdrawn | |
| 800820-021 | Withdrawn | |
| 800860-001 | Withdrawn | |
| 800810-021 | Withdrawn | |
| 800820-031 | Withdrawn | |
| 800820-011 | Withdrawn | |
| 800810-001 | Withdrawn | |
| 800860-021 | Withdrawn | |
| 700023-906 | Withdrawn | |
| 800860-011 | Withdrawn | |
| 800830-021 | Withdrawn | |
| 800810-011 | Withdrawn | |
| 800820-001 | Withdrawn | |
| 800860-031 | Withdrawn | |
| 800830-001 | Withdrawn | |
| 700023-905 | Withdrawn | |
| 800830-011 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Microlife | Microlife USA, Inc. | 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.