Data / Medical devices / United States / Innomed Healthscience, Inc.
Innomed Healthscience, Inc.: FDA-registered device maker in Deerfield Bch, FL, United States, 1 510(k) clearance
Innomed Healthscience, Inc. is registered with the FDA (registration 3014941496) in Deerfield Bch, FL, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 16, 2018. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3014941496
- Address
- 1701 W. Hillsboro Blvd Suite 303, Deerfield Bch, FL, United States, 33442
- Owner or operator
- Innomed Healthscience, Inc. (10058909)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- November 8, 2018
- Registered through
- 2026
- Brand names listed
- Bongo RX, ZValves
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dilator, Nasal | LWF | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea | OHP | 2 | 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 |
|---|---|---|---|---|---|---|
| August 16, 2018 | K180619 | Bongo | OHP | Substantially Equivalent | Innomed Healthscience, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Dilator, Nasal
- All makers of Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea
Updated August 16, 2018. 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.