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
- K952031ULTRASOUND TRANSDUCER, MODEL US9172Cleared 510(K)
- K923335ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATION2Cleared 510(K)
- K924516OP3/VP42Cleared 510(K)
- K903348ULTRASONIC PULSED DOPPLER IMAGING SYSTEM2Cleared 510(K)
- K900966EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBE2Cleared 510(K)
- K903316ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER2Cleared 510(K)
- K901142MER MULTIPLANE VAGINAL PROBE (MVP)2Cleared 510(K)
- K900838TRANSVAGINAL TRANSDUCER ASSEMBLY2Cleared 510(K)
- K895449ALOKA MODEL SSD-650 ULTRASOUND IMAGING SYSTEM2Cleared 510(K)
- K881263MODEL 500A VASCULAR SPECTRUM ANALYZER W/DOPPLER2Cleared 510(K)
- P800016TENNANT(TM) & KELMAN(TM) TYPE II2PMA Approval
- K8956475.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER2Cleared 510(K)
- P800016YENNANT(TM) & KELMAN(TM) TYPE II2PMA Approval
- K8951235.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER2Cleared 510(K)
- K895026HP MODEL M1318A TRANSVAGINAL ULTRASOUND TRANSDUCER2Cleared 510(K)
- K894415DYMAX ENDOVAGINAL BIOPSY GUIDE2Cleared 510(K)
- K892070GENERAL IVT NEEDLE GUIDE KIT, STERILE2Cleared 510(K)
- P800016TENNANT(TM) & KELMAN(TM) TYPE II2PMA Approval
- K881405SIEMENS INTRAVAGINAL TRANSDUCER2Cleared 510(K)
- P800016TENNANT(TM) & KELMAN(TM) TYPE II2PMA Approval
- K875371KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEM2Cleared 510(K)
- K875334KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEM2Cleared 510(K)
- K872265ULTRASOUND BREAST SCANNER W/CHANGES IN TRANS/RECE.2Cleared 510(K)
- K871856ANNULAR ARRAY SCANHEAD2Cleared 510(K)
- K8707097.5 MHZ ENDOVAGINAL PROBE2Cleared 510(K)
- K864908DIASONICS TRANSVAGINAL, TV 7.5 MHZ PROBE2Cleared 510(K)
- K864578ACUSON TV519 TRANSDUCER2Cleared 510(K)
- K864219TRANSVAGINAL ULTRASOUND BIOPSY NEEDLE GUIDE2Cleared 510(K)
- K864151280SL IMAGING SYSTEM TRANVAGINAL PROBES2Cleared 510(K)
- K863797BIOPSY NEEDLE GUIDE ATTACHMENT2Cleared 510(K)
- K861371TRANSVAGINAL PROBE, MODEL ED65M-TV2Cleared 510(K)
- K862072FETASCAN ULTRASOUND TRANSDUCER IBI# 101B00054-012Cleared 510(K)
- K861577ACUSON S228, S519 & L558 TRANSDUCERS2Cleared 510(K)
- K861578ACUSON S328, L382, L538 & L312 TRANSDUCERS2Cleared 510(K)
- P800016TENNANT(TM) & KELMAN(TM) TYPE II2PMA Approval
- K860234TRANSVAGINAL TRANSDUCER, 5MHZ2Cleared 510(K)
- K8606211MHZ CW DOPPLER TRANSDUCER W/LILY ANTEPARTUM #5072Cleared 510(K)
- K8603133.0 MHZ LINEAR ARRAY PROBE MODEL UST 50312Cleared 510(K)
- P800016TENNANT(TM) & KELMAN(TM) TYPE II2PMA Approval
- P800016TENNANT(TM) & KELMAN(TM) TYPE II2PMA Approval
- P800016TENNANT(TM) & KELMAN(TM) TYPE II2PMA Approval
- P800016TENNANT(TM) & KELMAN(TM) TYPE II2PMA Approval
- K827885BIO-DERM COUPLING LOTION2Cleared 510(K)
- K771869DIAG. ULTRASOUND B-SCANNER2Cleared 510(K)
- K771151ARTIUS SYSTEM2Cleared 510(K)
- 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
- 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
KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEM
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K875334
- 510(k) Type
- Traditional
- Applicant
- KONTRON INSTRUMENTS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/24/1988
- Days to Decision
- 85 days