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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic
510(k) Number K984307
Device Name MODIFICATION OF: RHEO DOPPLEX II
Applicant
Huntleigh Healthcare, Inc.
227 Rt. 33 E.
Manalapan,  NJ  07726
Applicant Contact AUDREY WITKO
Correspondent
Huntleigh Healthcare, Inc.
227 Rt. 33 E.
Manalapan,  NJ  07726
Correspondent Contact AUDREY WITKO
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Code
JOM  
Date Received12/02/1998
Decision Date 01/12/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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