Data / Medical devices / United States / Spaulding Medical, LLC
Spaulding Medical, LLC: FDA-registered device maker in Menomonee Falls, WI, United States, 1 510(k) clearance
Spaulding Medical, LLC is registered with the FDA (registration 3008921101) in Menomonee Falls, WI, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 12, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008921101
- Address
- 111 Heritage Reserve, Menomonee Falls, WI, United States, 53051
- Owner or operator
- Spaulding Medical, LLC (10057680)
- Roles
- Manufacturer
- First device listed
- May 12, 2018
- Registered through
- 2026
- Brand names listed
- Spaulding Electrocardiograph 2100iQ, webECG
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrocardiograph | DPS | 2 | Manufacturer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | 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 |
|---|---|---|---|---|---|---|
| August 12, 2015 | K150564 | Spaulding Electrocardiograph 2100iQ | DPS | Substantially Equivalent | Spaulding Clinical Research, LLC | accessdata.fda.gov |
Compare with other makers
Updated August 12, 2015. 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.