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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K942565
Device Name ALTAIR-DISC RECORDER
Applicant
Burdick Corp.
15 Plumb St.
Miltoon,  WI  53563
Applicant Contact PAUL E APPEL
Correspondent
Burdick Corp.
15 Plumb St.
Miltoon,  WI  53563
Correspondent Contact PAUL E APPEL
Regulation Number870.1425
Classification Product Code
DQK  
Date Received05/31/1994
Decision Date 12/05/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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