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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Fluoroscopic, Image-Intensified
510(k) Number K810189
Device Name SIRECON COMPACT
Applicant
Siemens Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Siemens Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number892.1650
Classification Product Code
JAA  
Date Received01/23/1981
Decision Date 03/02/1981
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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