Cleared Traditional

MOTIONSPECT

K895881 · Baltimore Therapeutic Equipment Co. · Gastroenterology & Urology
Apr 1990
Decision
187d
Days
Class 3
Risk

About This 510(k) Submission

K895881 is an FDA 510(k) clearance for the MOTIONSPECT, a Column, Adsorption, Low Density, Lipoprotein (Class III — Premarket Approval, product code LXW), submitted by Baltimore Therapeutic Equipment Co. (Hanover, US). The FDA issued a Cleared decision on April 10, 1990, 187 days after receiving the submission on October 5, 1989. This device falls under the Gastroenterology & Urology review panel.

Submission Details

510(k) Number K895881 FDA.gov
FDA Decision Cleared SESE
Date Received October 05, 1989
Decision Date April 10, 1990
Days to Decision 187 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code LXW — Column, Adsorption, Low Density, Lipoprotein
Device Class Class III — Premarket Approval