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510(k) K780487

Device
FETAL MONITORING SYSTEM
Applicant
SONICAID, INC.
510(k) number
K780487
Product code
HFO  
Decision
Substantially Equivalent (SESE)
Decision date
1978-05-09
Date received
1978-03-27
Regulation
884.2700
Classification name
Recorder, Pressure, Intrauterine
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
VA US

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HFO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K973850ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M007Alexander Mfg. Co.1997-11-12
K943989LAPAROSCOPIC/ENDOSCOPIC INSTRUEMENTGabris Surgical Corp.1994-09-12
K791633UC-2000 UTERINE CATHERIZATION SYSTEMLife Support, Inc.1979-09-17

Legacy Summary#

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FDA Review#

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