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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bottle, Collection, Vacuum
510(k) Number K844853
Device Name NIFA NON INVASIVE FLUTTER ASSEMBLY
Applicant
Emergency Management Products, Inc.
14724 Janice Dr.
Rockville,  MD  20853
Applicant Contact KENNETH A ZSELTVAY
Correspondent
Emergency Management Products, Inc.
14724 Janice Dr.
Rockville,  MD  20853
Correspondent Contact KENNETH A ZSELTVAY
Regulation Number880.6740
Classification Product Code
KDQ  
Date Received12/14/1984
Decision Date 12/12/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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