Data / Medical devices / United States / Prestige Medical
Prestige Medical: FDA-registered device maker in Grand Prairie, TX, United States, 10 510(k) clearances
Prestige Medical is registered with the FDA (registration 2081040) in Grand Prairie, TX, United States. It lists 10 device types. The FDA files 10 510(k) clearances under its listings, the newest dated November 28, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2081040
- Address
- 2750 113th St, Grand Prairie, TX, United States, 75050
- Owner or operator
- Rashman Corp. DBA Prestige Medical (2081040)
- Roles
- Repackager or relabeler
- First device listed
- January 27, 2022
- Registered through
- 2026
- Brand names listed
- 82, S82, 79, S79, 882, 80, A2, A1, A121 70 Basic, Standard, Premium Aneroids, PM 4200, 4220, 4200-B, 4220-B, PM 452 Pulse Oximeter, PM 459 DX Pulse Oximeter, PM Clinical, Traditional, Basic Stethoscopes, PM Clinical, Traditional, Basic, Clearsound Stethoscopes, PM DT-29 Infrared Thermometer, PM DT-30, 32 Infrared Thermometer and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Blood Pressure Cuff | DXQ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Bottle, Hot/Cold Water | FPF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Repackager or relabeler | accessdata.fda.gov |
| Fork, Tuning | GWX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Hammer, Surgical | FZY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Light, Examination, Medical, Battery Powered | KYT | 1 | Repackager or relabeler | accessdata.fda.gov |
| Oximeter | DQA | 2 | Repackager or relabeler | accessdata.fda.gov |
| Percussor | GWZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Stethoscope, Manual | LDE | 1 | Repackager or relabeler | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 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 28, 2022 | K222652 | Aneroid Sphygmomanometer; Single Patient Use Aneroid Sphygmomanometer | DXQ | Substantially Equivalent | Cardicare Company, Ltd. | accessdata.fda.gov |
| December 7, 2020 | K201384 | Pulse Oximeter | DQA | Substantially Equivalent | Shenzhen Raysintone Technology Co., Ltd. | accessdata.fda.gov |
| July 17, 2014 | K140682 | FINGERTIP PULSE OXIMETER | DQA | Substantially Equivalent | Beijing Choice Electronic Technololgy Co., Ltd. | accessdata.fda.gov |
| October 15, 2013 | K130231 | NON-CONTACT INFRARED THERMOMETER | FLL | Substantially Equivalent | Jinxinbao Electronic Co.,Ltd | accessdata.fda.gov |
| May 17, 2010 | K100953 | MICROLIFE NON-CONTACT INFRARED FOREHEAD THERMOMETER, MODEL FR1DZ1 | FLL | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| March 25, 2010 | K093831 | FULLY AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868RT | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| February 16, 2010 | K093824 | FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL158BT | DXN | Substantially Equivalent | Health & Life Co., Ltd. | accessdata.fda.gov |
| September 17, 2008 | K082542 | ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE MODEL HBPK-A | DXQ | Substantially Equivalent | Cardicare Company, Ltd. | accessdata.fda.gov |
| August 16, 2001 | K012444 | ABN ANEROID SPHYGMOMANOMETER | DXQ | Substantially Equivalent | Pt. Sugih Instrumendo Abadi | accessdata.fda.gov |
| May 23, 1985 | K851146 | DIGITAL THERMOMETER | FLL | Substantially Equivalent | Micro Idea Instrument Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Continuous Measurement Thermometer
- All makers of Blood Pressure Cuff
- All makers of Fork, Tuning
- All makers of Percussor
- All makers of Stethoscope, Manual
Updated November 28, 2022. 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.