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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Fetal Doppler Ultrasound
510(k) Number K090499
Device Name LIFEDOP MODEL, L350R
Applicant
Summit Doppler Systems, Inc.
4680 Table Mountain Dr. #150
Golden,  CO  80403
Applicant Contact KEN JARRELL
Correspondent
Tuv Sud America, Inc.
1775 Old Hwy. 8 NW
New Brighton,  MN  55112
Correspondent Contact DAWN TIBODEAU
Regulation Number884.2660
Classification Product Code
MAA  
Date Received02/25/2009
Decision Date 03/31/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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