ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR, 9FR, 12FR, 18FR, 24FR— 510(k) K111050

Substantially Equivalent

Starboard Medical, LLC

FDA 510(k) clearance K111050 for ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR, 9FR, 12FR, 18FR, 24FR, Substantially Equivalent on 2012-04-12. Applicant: Starboard Medical, LLC. Device class: 2.

Clearance details

Applicant
Starboard Medical, LLC
Product code
Code BZT
Device class
Class 2
Regulation
21 CFR 868.1920
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Yorba Linda, CA, US
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