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U.S. Department of Health and Human Services

510(k) Premarket Notification

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510(k) Number K850388
Device Name ITI 200 ELECTRIC MOTOR DRIVE, UNIV.-WHEELCHAIR ACC
Applicant
Instrument Technology, Inc.
1961 Old Middlefield Way
Mountain View,  CA  94043
Applicant Contact ROBERT TETRAULT
Correspondent
Instrument Technology, Inc.
1961 Old Middlefield Way
Mountain View,  CA  94043
Correspondent Contact ROBERT TETRAULT
Date Received02/01/1985
Decision Date 04/25/1985
Decision Substantially Equivalent (SESE)
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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