Precision Medical Inc.
PM5900,MONITOR,O2, DRW
1manufacturer
2catalogue numbers in this listing
Who Else Makes It
Registered in Guangdong. 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 |
Record
| Listed by | Precision Medical Technologies, United States |
|---|---|
| FDA product code | CCI |
| Device type | Analyzer, Gas, Nitrogen, Gaseous-Phase |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1690 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K063096 |
| Record published | 2024-09-23 |
| Record revised | 2024-07-04 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PM5900DRW | In distribution | |
| PM5900 | In distribution |
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.