Data / Medical devices / United States / Fluke Biomedical
Fluke Biomedical: FDA-registered device maker in Everett, WA, United States, 2 510(k) clearances
Fluke Biomedical is registered with the FDA (registration 2921581) in Everett, WA, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 24, 2008. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2921581
- Address
- 6920 Seaway BLVD., Everett, WA, United States, 98203
- Owner or operator
- Fluke Biomedical (9031860)
- Roles
- Manufacturer
- First device listed
- January 25, 2006
- Registered through
- 2026
- Brand names listed
- Clear-Pb, Impulse 6000D, Impulse 7000DP, Impulse 7010
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Shield, Protective, Personnel | KPY | 1 | Manufacturer | accessdata.fda.gov |
| Tester, Defibrillator | DRL | 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 |
|---|---|---|---|---|---|---|
| December 24, 2008 | K083347 | IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS | DRL | Substantially Equivalent | Fluke Biomedical | accessdata.fda.gov |
| January 28, 2008 | K072114 | IMPULSE 6000D/7000DP | DRL | Substantially Equivalent | Fluke Biomedical | accessdata.fda.gov |
Compare with other makers
Updated December 24, 2008. 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.