SpO2 Unit(Masimo)
Catalogue number 61625, listed by Atom Medical Corporation, Japan, under Warmer, Infant Radiant. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
1catalogue number
4510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (2), Guangdong (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 |
|---|---|---|---|---|
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Amphenol (Changzhou) Connector Systems Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 4 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
Record
| Listed by | Atom Medical Corporation, Japan |
|---|---|
| FDA product code | FMT |
| Device type | Warmer, Infant Radiant |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5130 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| Record published | 2016-09-21 |
| Record revised | 2019-01-29 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 61625 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DeRoyal | Deroyal Industries, Inc. | 37 |
| Fisher & Paykel Healthcare | Fisher & Paykel Healthcare, Ltd. | 9 |
| AirLife™ | AirLife Finland Oy | 8 |
| Tarry Probes | Tarry Medical Products, Inc. | 5 |
| Argyle | Cardinal Health | 5 |
| Panda | Datex-Ohmeda, Inc. | 4 |
| AccuTemp Probe | Kentec Medical, LLC | 3 |
| Ameritus | Kentec Medical, LLC | 3 |
| AirLife | Carefusion Finland 320 Oy | 3 |
| F&P Neopuff | Fisher & Paykel Healthcare, Ltd. | 2 |
| Sunflower Warmer, Stand AC120V | Atom Medical Corporation | 2 |
| Heating Element 540W-104V | RPI | 2 |
Showing 12 of 39. All products under Warmer, Infant Radiant
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K120937 | 2012-07-06 |
| K102227 | 2011-01-21 |
| K060461 | 2006-04-28 |
| K002355 | 2000-10-10 |
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.