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
- K242846Doppler FHR Detector (BF-500D+, BF-560)2Cleared 510(K)
- K233823Ultrasonic Fetal Doppler2Cleared 510(K)
- K232893Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F)2Cleared 510(K)
- K220245Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)2Cleared 510(K)
- K211940Fetal Doppler2Cleared 510(K)
- K212084Fetal Doppler2Cleared 510(K)
- K191110HeraBEAT™ US2Cleared 510(K)
- K182526Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D)2Cleared 510(K)
- K182710Fetal Doppler, Model FD882Cleared 510(K)
- K182190Fetal Doppler2Cleared 510(K)
- K180419Ultrasonic Doppler (Model YM-2T8)2Cleared 510(K)
- K172780SD1 Ultrasonic Pocket Doppler2Cleared 510(K)
- K153475SD5 & SD6 Ultrasonic Tabletop Doppler2Cleared 510(K)
- K140579ULTRASONIC POCKET DOPPLER2Cleared 510(K)
- K131457FETAL ULTRASONIC MONITOR AND ACCESSORIES2Cleared 510(K)
- K112911FETAL DOPPLER2Cleared 510(K)
- K112529TD-5000 & TD-6000 ULTRASONIC TABLETOP DOPPLER2Cleared 510(K)
- K111934PD-100 SERIES ULTRASONIC POCKET DOPPLER2Cleared 510(K)
- K110630F102Cleared 510(K)
- K110124FETAL DOPPLER JPD-100S2Cleared 510(K)
- K100626DOPPLER FETAL HEART RATE DETECTOR, MODEL FM-2002Cleared 510(K)
- K090510DOPPLER FETAL HEARTBEAT RATE DETECTOR2Cleared 510(K)
- K092997ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD62Cleared 510(K)
- K082480CONTEC POCKET FETAL DOPPLER2Cleared 510(K)
- K082055MODEL PC-860 FETAL DOPPLER2Cleared 510(K)
- K080087SONOTRAX ULTRASONIC FETAL AND VASCULAR POCKET DOPPLER, MODELS LITE, BASIC, PRO, II, II PRO AND VASCULAR2Cleared 510(K)
- K061091BABYBEAT CORDLESS2Cleared 510(K)
- K040480SONOTRAX ULTRASONIC POCKET DOPPLER2Cleared 510(K)
- K033156OB1 OBSTETRICAL DOPPLER2Cleared 510(K)
- K030466HANDYDOP2Cleared 510(K)
- K031504ECHO SOUNDER, SINGLE-HANDED, MODEL ES-101EX2Cleared 510(K)
- K024197LIFEDOP DOPPLER2Cleared 510(K)
- K023143ECHO SOUNDER, ES-102EX2Cleared 510(K)
- K013547BABYCOM2Cleared 510(K)
- K991441CADENCE DOPPLER ULTRASOUND SYSTEM2Cleared 510(K)
- K930200MULTI DOPPLEX II / FETAL DOPPLEX II2Cleared 510(K)
- K920056POCKET SIZE FETAL HEART DETECTOR2Cleared 510(K)
- K911453OBTRASOUND STETHOSCOPE FETAL CALC2Cleared 510(K)
- K910153UST-974-5 CONVEX TRANSDUCER2Cleared 510(K)
- K901593IMEX DOP-TONE II2Cleared 510(K)
- K900618HUNTLEIGH FETAL DOPPLER, FD-1 & DOPCORD, D1402Cleared 510(K)
- K890139TOITU DOPPLER FETUS DETECTOR, FD-400D2Cleared 510(K)
- K870653ULTRASOUND LINEAR/SECTOR SCANNER 11002Cleared 510(K)
- K870058PIE MEDICAL SCANNER 10002Cleared 510(K)
- K854267HUNTLEIGH DOPCORD, D1402Cleared 510(K)
- K852655COMBISCOPE2Cleared 510(K)
- K841805OBSTETRICAL DOPPLER2Cleared 510(K)
- K823242PROGRAMALITH PROGRAMMER2Cleared 510(K)
- K812868FETAL PULSE DETECTORS, F50/F602Cleared 510(K)
- K810115DOPPLEX-PLB & PXB2Cleared 510(K)
- K802024GRAVIDAPHONE2Cleared 510(K)
- K800858FETAL HEART DETECTOR #'S D102 & D102R2Cleared 510(K)
- K800859FETAL HEART DETECTOR #D2062Cleared 510(K)
- K800098MINIFETON 2002Cleared 510(K)
- K800095MGD-32Cleared 510(K)
- K790951SA/7860 FETAL HEART MONITOR (DOPPLER)2Cleared 510(K)
- K770904PROBE, BLOOD FLOW DETECTOR PLUG-IN2Cleared 510(K)
- K760888MODEL 6/60 CRT VIDEO-SONAR2Cleared 510(K)
- K760728CONTINUOUS WAVE DOPPLER ULTRASOUND2Cleared 510(K)
- 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
SONOTRAX ULTRASONIC FETAL AND VASCULAR POCKET DOPPLER, MODELS LITE, BASIC, PRO, II, II PRO AND VASCULAR
- Page Type
- Cleared 510(K)
- 510(k) Number
- K080087
- 510(k) Type
- Traditional
- Applicant
- Edan Instruments, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/11/2008
- Days to Decision
- 60 days
- Submission Type
- Summary