MAXO2ME
The FDA filing identifies MaxO2ME as a handheld oxygen analyzer and monitor that measures oxygen concentration from 0% to 100% in a sample gas. Its stated use is continuous monitoring of…
The FDA filing identifies MaxO2ME as a handheld oxygen analyzer and monitor that measures oxygen concentration from 0% to 100% in a sample gas.
Its stated use is continuous monitoring of oxygen concentration delivered to newborn through adult patients. The filing says it can be used in pre-hospital, hospital, and subacute settings.
Listed Item
MAXO2ME Monitor W/Blender KIT
Device Description and Stated Use
The filing also states that MaxO2ME is not intended as a life-supporting device.
Who Else Makes It
Concentrated in Guangdong (7), 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 |
| Orantech Inc. | Shenzhen | Guangdong | Contract manufacturer | 40 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Guangdong Biolight Meditech Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 19 |
| Unimed Medical Supplies Inc | Shenzhen | Guangdong | Contract manufacturer | 15 |
Record
| Listed by | Maxtec, LLC, United States |
|---|---|
| FDA product code | CCL |
| Device type | Analyzer, Gas, Oxygen, Gaseous-Phase |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1720 |
| 510(k) | K153659 |
| Record published | 2018-03-27 |
| Record revised | 2018-07-06 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| R230P01-002 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| O2-Sensor | IT DR. Gambert Gmbh | 90 |
| Analytical Industries Inc. | Analytical Industries, Inc. | 70 |
| Oxygen Sensor | Honeywell Healthcare Solutions GmbH | 40 |
| Vital Signs™ | AirLife Finland Oy | 27 |
| MaxVenturi | Maxtec, LLC | 24 |
| Sensoronics | Sensoronics Incorporated | 15 |
| NOxBOXi | Noxbox Limited | 15 |
| Teledyne Analytical Instruments | Teledyne Analytical Instrs | 14 |
| MiniOX | Ohio Medical LLC | 12 |
| Vital Signs | Carefusion Finland 320 Oy | 10 |
| Oxygen Sensor | Maxtec, LLC | 8 |
| MAX-250 | Maxtec, LLC | 7 |
Showing 12 of 165. All products under Analyzer, Gas, Oxygen, Gaseous-Phase
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K221734 | 2023-04-01 |
| K153659 | 2016-06-10 |
| K112402 | 2011-12-14 |
| K063488 | 2007-02-22 |
| K040484 | 2004-06-09 |
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.