Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Obstetrical and Gynecological Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Obstetrical and Gynecological Monitoring DevicesCFR Sub-Part
- HEQMonitor, Pressure, Arterial, Fetal, Ultrasonic2Product Code
- HEIMonitor, Heart-Valve Movement, Fetal, Ultrasonic2Product Code
- HEJMonitor, Hemic Sound, Ultrasonic2Product Code
- HEKMonitor, Heart Sound, Fetal, Ultrasonic2Product Code
- HELMonitor, Heart Rate, Fetal, Ultrasonic2Product Code
- HEMImager, Ultrasonic Obstetric-Gynecologic2Product Code
- HENCaliper, Fetal Head, Ultrasonic2Product Code
- HEOAnalyzer, Data, Obstetric3Product Code
- HEPMonitor, Blood-Flow, Ultrasonic2Product Code
- HFMMonitor, Uterine Contraction, External (For Use In Clinic)2Product Code
- HFNTransducer, Pressure, Intrauterine2Product Code
- HFORecorder, Pressure, Intrauterine2Product Code
- HFPMonitor, Phonocardiographic, Fetal2Product Code
- HGLTransducer, Ultrasonic, Obstetric2Product Code
- HGMSystem, Monitoring, Perinatal2Product Code
- HGNStethoscope, Fetal1Product Code
- HGOMonitor, Electroencephalographic, Fetal (And Accessories)3Product Code
- HGPElectrode, Circular (Spiral), Scalp And Applicator2Product Code
- HGSCatheter, Intrauterine And Introducer2Product Code
- HHJLocator, Intracorporeal Device, Ultrasonic, Obstetric-Gynecologic2Product Code
- HHXHolograph, Fetal, Acoustical2Product Code
- HIQElectrode, Clip, Fetal Scalp (And Applicator)3Product Code
- KNGMonitor, Ultrasonic, Fetal2Product Code
- KXNMonitor, Cardiac, Fetal2Product Code
- KXOMonitor, Pressure, Intrauterine2Product Code
- K991235SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP IUPC)2Cleared 510(K)
- K982565EASY TRANS TIP2Cleared 510(K)
- K974730SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUPC)2Cleared 510(K)
- K964279SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC)2Cleared 510(K)
- K961290IUP - TIP TRANS, IUP - PROXI TRANS2Cleared 510(K)
- K950498LIFE TRACE TRANS TIP INTRAUTERINE PRESSURE CATHETER2Cleared 510(K)
- K950708LIFETRACE INTRAUTERINE PRESSURE CATHETER IUP 30002Cleared 510(K)
- K922323MX4042/MC4044 SERIES SIMULCATH(TM)2Cleared 510(K)
- K920044DUAL LUMEN TRANSCERIVICAL INTRAUTERINE KIT2Cleared 510(K)
- K910742MEDI-TRACE DISPOSABLE INTRAUTERINE CATHETER2Cleared 510(K)
- K905563INTRAN PLUS2Cleared 510(K)
- K910227MX4043---SERIES, INTRAUTERINE PRESSURE CATHETER2Cleared 510(K)
- K901084ISOFLO INTRAUTERINE PRESSURE MONITORING & AMNIO.2Cleared 510(K)
- K896122AMNICATHDL(TM) DT-IUPC2 DUAL LUMEN TRANS. TIPPED2Cleared 510(K)
- K895763ISOFLO AND ISOTEC INTRAUTERINE PRESSURE MONITORING2Cleared 510(K)
- K895323MODEL DT-BAL, BALANCE SAVER2Cleared 510(K)
- K894362MODEL DT-IUPC2 TRANSDUCER TIPPED DUAL LUMEN IUP2Cleared 510(K)
- K885316DISPOSABLE INTRAUTERINE PRESSURE KIT MODEL 13972A2Cleared 510(K)
- K881857AMNICATH(TM) MODEL DT-IUPC TRANS. TIPPED INTRAU.2Cleared 510(K)
- K883832CATHETER, INTRAUTERINE AND INTRODUCER2Cleared 510(K)
- K862873IUC - INTRAUTERINE CATHETER2Cleared 510(K)
- K862182AMNIOINFUSION CATHETER2Cleared 510(K)
- K860101MX4040 INTRAUTERINE PRESSURE MONITORING KIT2Cleared 510(K)
- K801758MMI/GAELTEC CATHETER INTRAUTERINE2Cleared 510(K)
- K790678INTRAUTERINE CATHETER TIP2Cleared 510(K)
- K790418MODEL 8100 PRE-FILLED INTRAUTERINE2Cleared 510(K)
- LQKHome Uterine Activity Monitor2Product Code
- MOHMonitor, Heart Rate, Fetal, Non-Stress Test (Home Use)2Product Code
- NHMSheet, Recording, Breast Examination2Product Code
- NKASystem, Documentation, Breast Lesion2Product Code
- OSPUterine Electromyographic Monitor2Product Code
- NPBSystem, Monitoring, For Progress Of Labor2Product Code
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- Subpart D—Obstetrical and Gynecological Prosthetic DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Obstetrical and Gynecological Surgical DevicesCFR Sub-Part
- Subpart F—Obstetrical and Gynecological Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—Assisted Reproduction DevicesCFR Sub-Part
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
ISOFLO INTRAUTERINE PRESSURE MONITORING & AMNIO.
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K901084
- 510(k) Type
- Traditional
- Applicant
- HEALTHDYNE CARDIOVASCULAR, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/1/1990
- Days to Decision
- 86 days