Alarm, Blood-Pressure
Frame F5-01
7manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (6), 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 |
| Philips Goldway (Shenzhen) Industrial Inc. | Shenzhen | Guangdong | Specification developer | 7 |
Record
| Listed by | GE Healthcare Finland OY, Finland |
|---|---|
| FDA product code | DSJ |
| Device type | Alarm, Blood-Pressure |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1100 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K213363 |
| Record published | 2016-06-03 |
| Record revised | 2024-10-11 (version 4) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment humidity 15 to 90 % RH; Handling environment atmospheric pressure 70 to 106 KiloPascal; Handling environment temperature 10 to 35 °C; Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment temperature -20 to 60 °C; Storage environment humidity 10 to 90 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Frame F5-01 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sarns™ Modular Perfusion System 8000 | Terumo Cardiovascular Systems Corporation | 5 |
| EEG Module | Philips Medizin Systeme Böblingen GmbH | 1 |
| Comen | Shenzhen Comen Medical Instruments Co., Ltd. | 1 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| GE Healthcare Finland OY | 510(k) number | 2025-09-26 | Class II | Component change control | Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and pot | 3271 |
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.