Data / Medical devices / United States / Sedation Systems LLC
Sedation Systems LLC: FDA-registered device maker in Tierra Verde, FL, United States, 1 510(k) clearance
Sedation Systems LLC is registered with the FDA (registration 3007143859) in Tierra Verde, FL, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 5, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007143859
- Address
- 150 Pinellas Bayway South Suites 207, 208, Tierra Verde, FL, United States, 33715
- Owner or operator
- Sedation System, LLC (10026795)
- Roles
- Specification developer
- First device listed
- March 21, 2014
- Registered through
- 2026
- Brand names listed
- Disposable Breathing Circuit and Mask Kit, Nitroscav
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Anesthesia Breathing Circuit Kit (Adult & Pediatric) | OFP | 1 | Specification developer | accessdata.fda.gov |
| Apparatus, Gas-Scavenging | CBN | 2 | Specification developer | accessdata.fda.gov |
| Pump, Portable, Aspiration (Manual Or Powered) | BTA | 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 |
|---|---|---|---|---|---|---|
| May 5, 2017 | K160950 | MINISCAV | CBN | Substantially Equivalent | Sedation Systems, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Pump, Portable, Aspiration (Manual Or Powered)
- All makers of Apparatus, Gas-Scavenging
- All makers of Anesthesia Breathing Circuit Kit (Adult & Pediatric)
Updated May 5, 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.