Cleared Traditional

K925225 - THE BTE VECTOR; ANALYSIS SYSTEM FOR THE LOW BACK
(FDA 510(k) Clearance)

K925225 · Baltimore Therapeutic Equipment Co. · Neurology

Jun 1994

Decision

619d

Days

Class 1

Risk

K925225 is an FDA 510(k) clearance for the THE BTE VECTOR; ANALYSIS SYSTEM FOR THE LOW BACK, a Goniometer, Ac-powered (Class I — General Controls, product code KQX), submitted by Baltimore Therapeutic Equipment Co. (Hanover, US). The FDA issued a Cleared decision on June 27, 1994, 619 days after receiving the submission on October 16, 1992. This device falls under the Neurology review panel. Regulated under 21 CFR 888.1500.

Submission Details

510(k) Number	K925225 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 16, 1992
Decision Date	June 27, 1994
Days to Decision	619 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF