ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR (NON-STERILE),ESOPHAGEAL STETHOSCOPE TEMPERATURE WITH ATTACHED EAR PIECE
FDA 510(k) clearance K140134 · decided 2014-06-16
Clearance details
- K-number
- K140134
- Device name
- ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR (NON-STERILE),ESOPHAGEAL STETHOSCOPE TEMPERATURE WITH ATTACHED EAR PIECE
- Applicant
- Starboard Medical, LLC
- Decision
- Substantially Equivalent
- Date received
- 2014-01-17
- Decision date
- 2014-06-16
- Days to decision
- 150 days
- Clearance type
- Traditional
- Product code
- BZT
- Device class
- 2
- Regulation number
- 868.1920
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Yorba Linda, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.