Data / Medical devices / Taiwan / Anest Iwata Sparmax Co., Ltd.
Anest Iwata Sparmax Co., Ltd.: FDA-registered device maker in Dacun Changhua, Taiwan, 6 510(k) clearances
Anest Iwata Sparmax Co., Ltd. is registered with the FDA (registration 3006789357) in Dacun Changhua, Taiwan. It lists 3 device types. The FDA files 6 510(k) clearances under its listings, the newest dated September 3, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006789357
- Address
- No. 121, Sec. 3, Zhongshan Rd., Dacun Changhua, Taiwan, 51542
- Owner or operator
- ANEST IWATA SPARMAX CO., LTD. (10059043)
- Roles
- Manufacturer
- First device listed
- November 26, 2018
- Registered through
- 2026
- Brand names listed
- CX-500 Compressor, Cliq Aspirator DV-300, Cliq Aspirator DV-350, Cliq Aspirator, DV-300, Cliq Aspirator, model DV-300, SPARMAX ASPIRATOR, MODELS TC-2000V ND VC-701, Suction Pump, AS-XXXX (family series)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apparatus, Suction, Ward Use, Portable, Ac-Powered | JCX | 2 | Manufacturer | accessdata.fda.gov |
| Compressor, Air, Portable | BTI | 2 | Manufacturer | accessdata.fda.gov |
| Pump, Portable, Aspiration (Manual Or Powered) | BTA | 2 | 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 |
|---|---|---|---|---|---|---|
| September 3, 2020 | K201203 | Cliq Aspirator | BTA | Substantially Equivalent | Anest Iwata Sparmax Co., Ltd. | accessdata.fda.gov |
| July 23, 2018 | K181398 | DV-300 Aspirator | JCX | Substantially Equivalent | Ding Hwa Co., Ltd. | accessdata.fda.gov |
| June 23, 2014 | K140809 | CLIQ DV-300 ASPIRATOR | JCX | Substantially Equivalent | Ding Hwa Co., Ltd. | accessdata.fda.gov |
| April 28, 2014 | K140031 | SUCTION PUMP | JCX | Substantially Equivalent | Ding Hwa Co., Ltd. | accessdata.fda.gov |
| December 30, 2013 | K132308 | CLIQ DV-300 ASPIRATOR | JCX | Substantially Equivalent | Ding Hwa Co., Ltd. | accessdata.fda.gov |
| April 24, 2008 | K080005 | SPARMAX ASPIRATOR, MODELS TC-2000V ND VC-701 | JCX | Substantially Equivalent | Ding Hwa Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Apparatus, Suction, Ward Use, Portable, Ac-Powered
- All makers of Pump, Portable, Aspiration (Manual Or Powered)
- All makers of Compressor, Air, Portable
Updated September 3, 2020. 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.