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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Tomography, Computed, Emission
510(k) Number K810589
Device Name NEURO-ECAT
Applicant
Eg&G Ortec, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Eg&G Ortec, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number892.1200
Classification Product Code
KPS  
Date Received03/04/1981
Decision Date 04/10/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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