510(k) K111050
- Device
- ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR, 9FR, 12FR, 18FR, 24FR
- Applicant
- STARBOARD MEDICAL, LLC
- 510(k) number
- K111050
- Product code
- BZT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-04-12
- Date received
- 2011-04-15
- Regulation
- 868.1920
- Classification name
- Stethoscope, Esophageal, With Electrical Conductors
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ANTHONY BERAN
- Address
- 22845 Savi Ranch Pkwy. Suite H Yorba Linda CA US 92887 92887
FDA Registration Numbers#
- 2527072
- 2032273
- 1055236
- 1927197
- 3007007790
- 9617604
- 2936999
- 3006845687
- 1928237
- 3012307300
- 9613793
- 1043214
- 3018094310
- 2032112
- 2246552
- 2030624
- 3003915875
- 3023031046
- 9681384
- 3006845683
- 1054241
- 8022257
- 2432320
- 1721686
Source Documents#
Other 510(k) Records For Product Code BZT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251025 | Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049) | Covidien, LLC | 2025-12-29 |
| K193027 | Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French | Deroyal Industries, Inc. | 2020-04-02 |
| K140134 | ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR (NON-STERILE),ESOPHAGEAL STETHOSCOPE TEMPERATURE WITH ATTACHED EAR PIECE | Starboard Medical, LLC | 2014-06-16 |
| K092716 | ESOPHAGEAL STETHOSCOPE | Truer Medical, Inc. | 2009-09-17 |
| K072621 | ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR | Cincinnati Sub-Zero Products, Inc. | 2007-12-13 |
| K062020 | LIFESOUND ESOPHAGEAL STETHOSCOPE | Novamed, LLC | 2006-09-05 |
| K982193 | ESOPHAGEAL STETHOSCOPE | Shore Medical, Inc. | 1998-09-01 |
| K973839 | DISPOSABLE ESOPHAGEAL STETHOSCOPE | Catheter Research, Inc. | 1998-03-19 |
| K961060 | ARISTO ESOPHAGEAL STETHOSCOPE | Aristo Medical Products, Inc. | 1996-06-19 |
| K953793 | INTROSCOPE | Polamedco, Inc. | 1995-11-29 |
| K930929 | ESOPHAGEAL STETHOSCOPE | Coast Medical Corp. | 1995-03-17 |
| K943495 | DISPOSABLE ESOPHAGEAL STETHOSCOPE | Coast Medical, Inc. | 1994-09-08 |
| K940169 | DEBUSK TEMPERATURE SYSTEMS PREMIER AND SIGNATURE SERIES MULTI-PURPOSE ESOPHAGEAL STETHOSCOPE | Deroyal Industries, Inc. | 1994-07-28 |
| K925789 | DEBUSK TEMP. SYST. ESOPHAGEAL STETHOSCOPE | Deroyal Industries, Inc. | 1993-07-13 |
| K930533 | BNOS MICROVENT(TM), MODEL AC AND MODEL AO | Bnos Meditech, Ltd. | 1993-03-29 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases