Data / Medical devices / United States / Volex Inc
Volex Inc: FDA-registered device maker in San Diego, CA, United States, 1 510(k) clearance
Volex Inc is registered with the FDA (registration 3010783192) in San Diego, CA, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 27, 2003. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010783192
- Address
- 9355 Airway Rd Ste 4, San Diego, CA, United States, 92154
- Owner or operator
- Volex Inc (10047472)
- Roles
- Repackager or relabeler
- First device listed
- September 12, 2014
- Registered through
- 2026
- Brand names listed
- Philips
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated External Defibrillators (Non-Wearable) | MKJ | 3 | Repackager or relabeler | accessdata.fda.gov |
| Dc-Defibrillator, Low-Energy, (Including Paddles) | LDD | 2 | Repackager or relabeler | accessdata.fda.gov |
| Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) | DRO | 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 |
|---|---|---|---|---|---|---|
| August 27, 2003 | K031187 | HEARTSTART MRX, MODEL M3535A | MKJ | Substantially Equivalent | Philips Medical Systems | accessdata.fda.gov |
Compare with other makers
- All makers of Automated External Defibrillators (Non-Wearable)
- All makers of Dc-Defibrillator, Low-Energy, (Including Paddles)
- All makers of Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
Updated August 27, 2003. 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.