Data / Medical devices / United States / Isovac Products LLC
Isovac Products LLC: FDA-registered device maker in Romeoville, IL, United States, 2 510(k) clearances
Isovac Products LLC is registered with the FDA (registration 3006076009) in Romeoville, IL, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 2, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006076009
- Address
- 1306 Enterprise Dr Ste C, Romeoville, IL, United States, 60446
- Owner or operator
- ISOVAC PRODUCTS LLC (9070989)
- Roles
- Manufacturer
- First device listed
- December 29, 2006
- Registered through
- 2026
- Brand names listed
- CAPSULS, ORCA
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Chamber, Patient Isolation | LGM | 2 | Manufacturer | accessdata.fda.gov |
| Chamber, Patient Transport Isolation | LGN | 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 |
|---|---|---|---|---|---|---|
| November 2, 2017 | K163223 | ORCA (tm) - Operational Rescue Containment Apparatus | LGM | Substantially Equivalent | Isovac Products, LLC | accessdata.fda.gov |
| June 6, 2006 | K052798 | CAPSULS, MODELS 2003-PUR8C, 2004-PVC8C | LGN | Substantially Equivalent | Isovac Products, LLC | accessdata.fda.gov |
Compare with other makers
Updated November 2, 2017. 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.