Dial Flowmeter
7MFA Series Dial Flowmeters (Oxygen)
5manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (3), Zhejiang (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Danyang Xinya Valve Co., Ltd. | Danyang | Jiangsu | Contract manufacturer | 17 |
| Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | Danyang | Jiangsu | Contract manufacturer | 37 |
| Danyang Airtech Co., Ltd. | Danyang | Jiangsu | Contract manufacturer | 7 |
| Yuyao Jiahua Medical Appliance, Co., Ltd. | Yuyao | Zhejiang | Manufacturer | 5 |
| Foshan Kycare Medical Equipment Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 3 |
Record
| Listed by | Precision Medical Technologies, United States |
|---|---|
| FDA product code | BXY |
| Device type | Flowmeter, Calibration, Gas |
| Device class | Class 1 |
| Regulation | 21 CFR 868.2350 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-04-05 |
| Record revised | 2024-07-02 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7MFA O2 SERIES | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Manifold | Maxtec, LLC | 10 |
| DFB Flowmeter | Maxtec, LLC | 10 |
| Acrylic Flowmeter | Maxtec, LLC | 10 |
| EM | Allied Medical LLC | 6 |
| Flowmeter | Maxtec, LLC | 4 |
| BlenderBuddy | Maxtec, LLC | 3 |
| Repair Parts | Sunset Healthcare Solutions, Inc. | 3 |
| Responsive Respiratory, Inc. | Responsive Respiratory Inc. | 3 |
| Flowmeter, Calibration, Gas | Salter Labs | 3 |
| Flowmeter Manifold | Maxtec, LLC | 3 |
| SureFlow | Caire Inc. | 3 |
| Flotec | Flotec, Inc. | 1 |
Showing 12 of 29. All products under Flowmeter, Calibration, Gas
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K902916 | 1990-07-23 |
| K902917 | 1990-07-23 |
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.