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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K827286
Device Name MODEL 8000 SECTOR IMAGER SYSTEM
Applicant
Ote Biomedica
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Ote Biomedica
4221 Richmond Rd., NW
Walker,  MI  49534
Date Received06/15/1982
Decision Date 08/06/1982
Decision Substantially Equivalent (SESE)
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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