Data / Medical devices / United States / Innovamed Sphere Inc
Innovamed Sphere Inc: FDA-registered device maker in Fall River, MA, United States, 2 510(k) clearances
Innovamed Sphere Inc is registered with the FDA (registration 3043355869) in Fall River, MA, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated June 18, 2009. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3043355869
- Address
- 2 Bank St, Fall River, MA, United States, 02720
- Owner or operator
- INNOVAMED SPHERE INC (10095268)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- February 16, 2026
- Registered through
- 2026
- Brand names listed
- BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM, BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM, MODEL NICAS 2004
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Plethysmograph, Impedance | DSB | 2 | Complaint file establishment, Specification developer | 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 |
|---|---|---|---|---|---|---|
| June 18, 2009 | K080941 | BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM | DSB | Substantially Equivalent | N.I. Medical, Ltd. | accessdata.fda.gov |
| July 16, 2007 | K070500 | BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM, MODEL NICAS 2004 SLIM | DSB | Substantially Equivalent | Ni Medical | accessdata.fda.gov |
Compare with other makers
Updated June 18, 2009. 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.