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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Hematocrit, Automated
510(k) Number K880373
Device Name IONOMETER E-HK AND ACCESSORIES
Applicant
Smash Ent., Inc.
3585 Lexington Ave. N.
Suite 258
Arden Hills,  MN  55126
Applicant Contact STEVEN V BUSLI
Correspondent
Smash Ent., Inc.
3585 Lexington Ave. N.
Suite 258
Arden Hills,  MN  55126
Correspondent Contact STEVEN V BUSLI
Regulation Number864.5600
Classification Product Code
GKF  
Date Received01/27/1988
Decision Date 03/17/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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