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510(k) K780035

Device
MINIVISOR
Applicant
METRIX TEKNIKA, INC.
510(k) number
K780035
Product code
HEL  
Decision
Substantially Equivalent (SESE)
Decision date
1978-03-06
Date received
1978-01-09
Regulation
884.2660
Classification name
Monitor, Heart Rate, Fetal, Ultrasonic
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HEL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K003876US SENSOR #CG-930P; TOCO SENSOR CG-940PCard Guard Scientific Survival , Ltd.2001-07-09
K010920TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORINGMedical Cables, Inc.2001-06-22
K982651COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCERCorometrics Medical Systems, Inc.1998-12-11
K971240ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M006Alexander Mfg. Co.1997-06-06
K930714SONICAID MODEL TEAM FECG IUPOxford Instruments, Plc.1995-08-24
K933816SONICAID MODEL P110 FETAL HEAR DETECTOROxford Instruments, Plc.1994-12-22

Legacy Summary#

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FDA Review#

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