Data / Medical devices / United States / Outlook Group, LLC
Outlook Group, LLC: FDA-registered device maker in Neenah, WI, United States, 3 510(k) clearances
Outlook Group, LLC is registered with the FDA (registration 2183924) in Neenah, WI, United States. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated March 1, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2183924
- FEI number
- 1000116132
- Address
- 1180 American Drive, Neenah, WI, United States, 54956
- Owner or operator
- Outlook Group, LLC. (9000092)
- Roles
- Repackager or relabeler
- First device listed
- January 15, 2020
- Registered through
- 2026
- Brand names listed
- 874.3900, Braun Lens Filter/ Probe Cover, Braun Probe Cover
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory Equipment, Cardiopulmonary Bypass | KRI | 1 | Repackager or relabeler | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Repackager or relabeler | accessdata.fda.gov |
| Dilator, Nasal | LWF | 1 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| March 1, 2016 | K152748 | Braun Thermoscan PRO 6000 Ear Thermometer | FLL | Substantially Equivalent | Kaz USA, Inc (A Subsidiary of Helen of Troy, Inc) | accessdata.fda.gov |
| January 26, 2011 | K103800 | BRAUN THERMOSCAN PRO 4000 SERIES AND BRAUN THERMOSCAN IRT 4000 SERIES CLINICAL INFRARED EAR THERMOMETERS | FLL | Substantially Equivalent | Kaz USA, Inc (A Subsidiaryof Kaz Inc) | accessdata.fda.gov |
| August 4, 2010 | K101747 | BRAUN THERMOSCAN PRO 4000 SERIES AND BRAUN THERMOSCAN IRT 4000 SERIES MODEL 6021791-PRO 4000 SERIES, 6022790-IRT 4000 SE | FLL | Substantially Equivalent | Kaz USA, Inc (A Subsidiaryof Kaz Inc) | accessdata.fda.gov |
Compare with other makers
- All makers of Accessory Equipment, Cardiopulmonary Bypass
- All makers of Dilator, Nasal
- All makers of Continuous Measurement Thermometer
Updated March 1, 2016. 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.