Data / Medical devices / Taiwan / Acare Technology Co., Ltd.
Acare Technology Co., Ltd.: FDA-registered device maker in New Taipei City, Taiwan, 6 510(k) clearances
Acare Technology Co., Ltd. is registered with the FDA (registration 3006395447) in New Taipei City, Taiwan. It lists 11 device types. The FDA files 6 510(k) clearances under its listings, the newest dated August 23, 2019. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3006395447
- Address
- 5F-4, No.24, Wuquan 2nd Rd Xinzhuang District, New Taipei City, Taiwan, 242
- Owner or operator
- ACARE TECHNOLOGY CO., LTD. (9096601)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler
- First device listed
- January 12, 2007
- Registered through
- 2027
- Brand names listed
- AC-SJ, AC-SJ-20 (Suction Bottle), AC-ST, AC-ST9 (Safety Trap), AE-M1, AE-O2, AH-M1, AH-MX and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Airway, Oropharyngeal, Anesthesiology | CAE | 1 | Exporter to the US | accessdata.fda.gov |
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | GCX | 2 | Manufacturer | accessdata.fda.gov |
| Apparatus, Suction, Ward Use, Portable, Ac-Powered | JCX | 2 | Manufacturer | accessdata.fda.gov |
| Bottle, Collection, Vacuum | KDQ | 2 | Manufacturer | accessdata.fda.gov |
| Cannula, Nasal, Oxygen | CAT | 1 | Exporter to the US | accessdata.fda.gov |
| Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge | CCN | 1 | Manufacturer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Contract manufacturer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Regulator, Pressure, Gas Cylinder | CAN | 1 | Manufacturer | accessdata.fda.gov |
| Regulator, Vacuum | KDP | 2 | Manufacturer | accessdata.fda.gov |
| Strap, Head, Gas Mask | BTK | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 23, 2019 | K182950 | Acare Suction Unit | JCX | Substantially Equivalent | Acare Technology Co., Ltd. | accessdata.fda.gov |
| December 22, 2011 | K111617 | PULSE OXIMETER MODEL AB-F1/AH-S1/AH-M1 | DQA | Substantially Equivalent | Acare Technology Co., Ltd. | accessdata.fda.gov |
| September 8, 2010 | K101694 | HANDHELD PULSE OXIMETER MODEL M800 | DQA | Substantially Equivalent | Guangdong Biolight Meditech Co., Ltd. | accessdata.fda.gov |
| March 3, 2010 | K093757 | MD300C1 FINGERTIP PULSE OXIMETER | DQA | Substantially Equivalent | Beijing Choice Electronic Technololgy Co., Ltd. | accessdata.fda.gov |
| January 14, 2008 | K072825 | FINGERTIP PULSE OXIMETER, MODEL MD300I | DQA | Substantially Equivalent | Beijing Choice Electronic Technololgy Co., Ltd. | accessdata.fda.gov |
| August 13, 2007 | K070371 | FINGERTIP PULSE OXIMETER MD300C | DQA | Substantially Equivalent | Beijing Choice Electronic Technololgy Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Airway, Oropharyngeal, Anesthesiology
- All makers of Bottle, Collection, Vacuum
- All makers of Cannula, Nasal, Oxygen
- All makers of Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge
- All makers of Oximeter
- All makers of Non-Surgical Gown
Updated August 23, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.