The following data is part of a premarket notification filed by Starboard Medical, Llc with the FDA for Disposable Temperature Probes / Sensors And Interconnect Instrument Cables.
| Device ID | K111282 |
| 510k Number | K111282 |
| Device Name: | DISPOSABLE TEMPERATURE PROBES / SENSORS AND INTERCONNECT INSTRUMENT CABLES |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | STARBOARD MEDICAL, LLC 22845 SAVI RANCH PKWY SUITE H Yorba Linda, CA 92887 |
| Contact | Anthony Beran |
| Correspondent | Anthony Beran STARBOARD MEDICAL, LLC 22845 SAVI RANCH PKWY SUITE H Yorba Linda, CA 92887 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-06 |
| Decision Date | 2011-08-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850933007105 | K111282 | 000 |
| 10850933007099 | K111282 | 000 |
| 10850933007082 | K111282 | 000 |
| 10897392002746 | K111282 | 000 |
| 10897392003095 | K111282 | 000 |
| 10897392003088 | K111282 | 000 |
| 10080196551644 | K111282 | 000 |