The following data is part of a premarket notification filed by Starboard Medical, Llc with the FDA for Esophageal Stethoscope With Temperature Sensor (non-sterile),esophageal Stethoscope Temperature With Attached Ear Piece.
| Device ID | K140134 |
| 510k Number | K140134 |
| Device Name: | ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR (NON-STERILE),ESOPHAGEAL STETHOSCOPE TEMPERATURE WITH ATTACHED EAR PIECE |
| Classification | Stethoscope, Esophageal, With Electrical Conductors |
| Applicant | STARBOARD MEDICAL, LLC 22845 Savi Ranch Pkwy Ste H Yorba Linda, CA 92887 |
| Contact | Anthony Beran |
| Correspondent | Anthony Beran STARBOARD MEDICAL, LLC 22845 Savi Ranch Pkwy Ste 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 | 2014-01-17 |
| Decision Date | 2014-06-16 |
| Summary: | summary |