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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Ultrasonic, Fetal
510(k) Number K810115
Device Name DOPPLEX-PLB & PXB
Applicant
Huntleigh Technology, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Huntleigh Technology, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number884.2660
Classification Product Code
KNG  
Date Received01/16/1981
Decision Date 07/16/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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