MAX-13C
Catalogue number R115P01, listed by Maxtec, LLC, United States, under Analyzer, Gas, Oxygen, Gaseous-Phase. 8 manufacturers in China are registered for this product code.
8manufacturers in China registered for this device type
1catalogue number
5510(k) clearances naming this product code
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) | K972992 |
| Record published | 2016-09-24 |
| Record revised | 2019-01-14 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| R115P01 | 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.