Data / Medical devices / United States / Starboard Medical, Inc.
Starboard Medical, Inc.: FDA-registered device maker in Irvine, CA, United States, 3 510(k) clearances
Starboard Medical, Inc. is registered with the FDA (registration 3006845683) in Irvine, CA, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated June 16, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006845683
- Address
- 18001 Sky Park Circle Suite E-F, Irvine, CA, United States, 92614
- Owner or operator
- Starboard Medical Inc. (10024475)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- October 30, 2012
- Registered through
- 2026
- Brand names listed
- Clarisonus Plus, Starboard Medical Esophageal Stethoscope with Temperature Sensor, Starboard Medical Skin Temperature Sensors, Starboard Medical Tympanic Temperature Sensors
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Stethoscope, Esophageal, With Electrical Conductors | BZT | 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 16, 2014 | K140134 | ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR (NON-STERILE),ESOPHAGEAL STETHOSCOPE TEMPERATURE WITH ATTACHED EAR PIECE | BZT | Substantially Equivalent | Starboard Medical, LLC | accessdata.fda.gov |
| April 12, 2012 | K111050 | ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR, 9FR, 12FR, 18FR, 24FR | BZT | Substantially Equivalent | Starboard Medical, LLC | accessdata.fda.gov |
| August 11, 2011 | K111282 | DISPOSABLE TEMPERATURE PROBES / SENSORS AND INTERCONNECT INSTRUMENT CABLES | FLL | Substantially Equivalent | Starboard Medical, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Continuous Measurement Thermometer
- All makers of Stethoscope, Esophageal, With Electrical Conductors
Updated June 16, 2014. 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.