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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Uterine Contraction, External (For Use In Clinic)
510(k) Number K873150
Device Name PDS, MODEL NST 40 FETAL MONITOR, RECORDER & TRANS.
Applicant
Pediatric Diagnostic Service
221 Third St.
Cambridge,  MA  02141
Applicant Contact JEFFREY KOEPSELL
Correspondent
Pediatric Diagnostic Service
221 Third St.
Cambridge,  MA  02141
Correspondent Contact JEFFREY KOEPSELL
Regulation Number884.2720
Classification Product Code
HFM  
Date Received08/11/1987
Decision Date 03/11/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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