Portrait Cssxb
Portrait Core Services Software V1.2.0
8manufacturers in China registered for this device type
1catalogue number
6510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (5), Jiangsu (1), Hebei (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Wuhan Strong Electronics | Wuhan | Hubei | Contract manufacturer | 6 |
| Ryder Electronics (Shenzhen) Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Dongguan Smart Manufacturing Partner Electronic Company Limited | Dongguan | Guangdong | Contract manufacturer | 1 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Contec Medical Systems Co., Ltd. | Qinhuangdao | Hebei | Manufacturer | 22 |
| Guangdong Biolight Meditech Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 19 |
Record
| Listed by | GE Medical Systems Information Technologies, Inc., United States |
|---|---|
| FDA product code | BZQ |
| Device type | Monitor, Breathing Frequency |
| Device class | Class 2 |
| Regulation | 21 CFR 868.2375 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K234130 |
| Record published | 2025-12-10 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CSSXB | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Perfect Fit | Dymedix Diagnostics Inc | 189 |
| Monitor, Breathing Frequency | ConMed Corporation | 106 |
| Monitor, Breathing Frequency | Salter Labs | 52 |
| Conmed | ConMed Corporation | 46 |
| Cadwell | Cadwell Industries, Inc. | 44 |
| Sensor | Respironics Inc. | 42 |
| ThermiSense | Salter Labs | 33 |
| SnuggleFit | Dymedix Diagnostics Inc | 23 |
| Braebon Cable for Disposable RIP | Braebon Medical Corp. | 5 |
| PneumoTherm | Salter Labs | 4 |
| BiNAPS | Salter Labs | 4 |
| SleepmatePiezo Crystal Sensor & Band, Adult/Ped, Double Buckle, Alice | Ambu A/S | 4 |
Showing 12 of 248. All products under Monitor, Breathing Frequency
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K962781 | 1997-03-06 |
| K943308 | 1995-07-25 |
| K942170 | 1995-06-02 |
| K873791 | 1987-11-23 |
| K861407 | 1986-05-14 |
| K850504 | 1985-06-24 |
Recalls Naming This Product
4 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| GE Medical Systems Information Technologies, Inc. | 510(k) number | 2026-07-20 | Class II | Device Design | Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings previously configured fo | 23 units |
| GE Medical Systems Information Technologies, Inc. | 510(k) number | 2026-07-20 | Class II | Device Design | Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings previously configured fo | 4 units |
| GE Medical Systems Information Technologies, Inc. | 510(k) number | 2026-07-10 | Class II | Software design | Portrait Core Services Software version V1.2.0 Security Vulnerability | 11 units |
| GE Medical Systems, LLC | 510(k) number | 2024-12-06 | Class II | Software design | There is a software issue that can result in the loss of patient monitoring on the Portrait Central Viewer Application after 425 days of continuous run-time. | 7 systems |
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.