Data / Medical devices / United States / Healthtex Distributors, Inc.
Healthtex Distributors, Inc.: FDA-registered device maker in Miami, FL, United States, 5 510(k) clearances
Healthtex Distributors, Inc. is registered with the FDA (registration 3000206696) in Miami, FL, United States. It lists 5 device types. The FDA files 5 510(k) clearances under its listings, the newest dated November 29, 2018. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3000206696
- Address
- 3555 NW 41 Street, Miami, FL, United States, 33142
- Owner or operator
- Healthtex Distributors, Inc. (10027903)
- Roles
- Repackager or relabeler
- First device listed
- April 4, 2020
- Registered through
- 2026
- Brand names listed
- Digital Thermometer, Face Mask, Gown, Oximeter, Oximeter Acurio, Thermometer
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Repackager or relabeler | accessdata.fda.gov |
| Clinical Electronic Thermometer | SDV | 2 | Repackager or relabeler | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Repackager or relabeler | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Oximeter | DQA | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| November 29, 2018 | K180685 | AS-3XX Series Fingertip Pulse Oximeter | DQA | Substantially Equivalent | Xiamen Acurio Instruments Co., Ltd. | accessdata.fda.gov |
| September 19, 2017 | K163135 | Finger Pulse Oximeter | DQA | Substantially Equivalent | Shenzhen Fitfaith Technology Co.,Ltd | accessdata.fda.gov |
| December 31, 2015 | K152508 | Ageless Health Medical Digital Thermometer | FLL | Substantially Equivalent | Dongguan Ageless Health Industrial Co., Ltd. | accessdata.fda.gov |
| October 15, 2013 | K130231 | NON-CONTACT INFRARED THERMOMETER | FLL | Substantially Equivalent | Jinxinbao Electronic Co.,Ltd | accessdata.fda.gov |
| August 3, 2010 | K101387 | DIGITAL THERMOMETER, MODELS BT-A11CN, BT-A21CN, BT-A41CN | FLL | Substantially Equivalent | Fudakang Industries Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Continuous Measurement Thermometer
- All makers of Clinical Electronic Thermometer
- All makers of Oximeter
- All makers of Accessory, Surgical Apparel
- All makers of Non-Surgical Gown
Updated November 29, 2018. 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.