VENNER TRACHEAL SEAL MONITOR


Device Classification Name

cuff, tracheal tube, inflatable

510(k) Number K110631
Device Name VENNER TRACHEAL SEAL MONITOR
Applicant
VENNER MEDICAL (SINGAPORE) PTE LTD
7 trail house court
rockville, 
MD 
20850

Applicant Contact hchristine brauer, ph.d.
Correspondent
VENNER MEDICAL (SINGAPORE) PTE LTD
7 trail house court
rockville, 
MD 
20850

Correspodent Contact hchristine brauer, ph.d.
Regulation Number 868.5750
Classification Product Code
BSK  
Date Received 03/04/2011
Decision Date 07/28/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No