The following data is part of a premarket notification filed by Starboard Medical, Llc with the FDA for Esophageal / Rectal Temperature Probe, 9fr, 12fr, Esophageal Stethoscope With Temperature Sensor, 9fr, 12fr, 18fr, 24fr.
| Device ID | K111050 |
| 510k Number | K111050 |
| Device Name: | ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR, 9FR, 12FR, 18FR, 24FR |
| Classification | Stethoscope, Esophageal, With Electrical Conductors |
| 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 | BZT |
| CFR Regulation Number | 868.1920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-15 |
| Decision Date | 2012-04-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850933007075 | K111050 | 000 |
| 00897392002572 | K111050 | 000 |
| 10897392003033 | K111050 | 000 |
| 10897392003040 | K111050 | 000 |
| 00897392002602 | K111050 | 000 |
| 10897392003064 | K111050 | 000 |
| 10897392003071 | K111050 | 000 |
| 10850933007020 | K111050 | 000 |
| 10850933007037 | K111050 | 000 |
| 10850933007044 | K111050 | 000 |
| 10850933007051 | K111050 | 000 |
| 10850933007068 | K111050 | 000 |
| 10813799005456 | K111050 | 000 |