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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Column, Adsorption, Low Density, Lipoprotein
510(k) Number K895881
Device Name MOTIONSPECT
Applicant
Baltimore Therapeutic Equipment Co.
7455-L New Ridge Rd.
Hanover,  MD  21076
Applicant Contact DAY III
Correspondent
Baltimore Therapeutic Equipment Co.
7455-L New Ridge Rd.
Hanover,  MD  21076
Correspondent Contact DAY III
Classification Product Code
LXW  
Date Received10/05/1989
Decision Date 04/10/1990
Decision Substantially Equivalent (SESE)
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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