Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- FCPBox, Battery, Pocket1Product Code
- FCQLight Source, Incandescent, Diagnostic2Product Code
- EXQCystometer, Electrical Recording2Product Code
- EXRUrinometer, Mechanical2Product Code
- EXSUrinometer, Electrical2Product Code
- EXWPill, Radio2Product Code
- EXYUroflowmeter2Product Code
- EXZEquipment, Photographic, For Physiologic Function Monitor1Product Code
- FAJCystoscope And Accessories, Flexible/Rigid2Product Code
- FAKPanendoscope (Gastroduodenoscope)2Product Code
- FALPanendoscope (Urethroscope)2Product Code
- FAMSigmoidoscope And Accessories, Flexible/Rigid2Product Code
- FANSigmoidoscope, Rigid, Electrical2Product Code
- FAPCystometric Gas (Carbon-Dioxide) On Hydraulic Device2Product Code
- FBIRongeur, Cystoscopic2Product Code
- FBKEndoscopic Injection Needle, Gastroenterology-Urology2Product Code
- FBNCholedochoscope And Accessories, Flexible/Rigid2Product Code
- FBOCystourethroscope2Product Code
- FBPTelescope, Rigid, Endoscopic2Product Code
- FCCEndoscopic Magnetic Retriever2Product Code
- FCFInstrument, Biopsy, Mechanical, Gastrointestinal2Product Code
- FCGBiopsy Needle2Product Code
- FCIPunch, Biopsy2Product Code
- FCKInstrument, Biopsy, Suction2Product Code
- FCLForceps, Biopsy, Non-Electric1Product Code
- FCOBox, Battery, Rechargeable1Product Code
- FCRLight Source, Photographic, Fiberoptic2Product Code
- FCWLight Source, Fiberoptic, Routine2Product Code
- FCXInsufflator, Automatic Carbon-Dioxide For Endoscope2Product Code
- FCYBulb, Inflation, For Endoscope1Product Code
- FCZTube, Smoke Removal, Endoscopic1Product Code
- FDAEnteroscope And Accessories2Product Code
- FDCResectoscope, Working Element2Product Code
- FDELaparoscopy Kit2Product Code
- FDFColonoscope And Accessories, Flexible/Rigid2Product Code
- FDRSphyncteroscope2Product Code
- FDSGastroscope And Accessories, Flexible/Rigid2Product Code
- FDTDuodenoscope And Accessories, Flexible/Rigid2Product Code
- FDWEsophagoscope, Rigid, Gastro-Urology2Product Code
- FDXEndoscopic Cytology Brush2Product Code
- FDYDevice, Measuring, For Panendoscope1Product Code
- FDZAttachment, Eyepiece, For Insertion Of Prescription Lens1Product Code
- FEAAttachment, Teaching, For Endoscope1Product Code
- FECObturator, For Endoscope2Product Code
- FEDEndoscopic Access Overtube, Gastroenterology-Urology2Product Code
- FEIInstrument, Special Lens, For Endoscope1Product Code
- FEJAttachment, Binocular, For Endoscope1Product Code
- FEMAccessories, Photographic, For Endoscope (Exclude Light Sources)1Product Code
- FENDevice, Cystometric, Hydraulic2Product Code
- FEQPump, Air, Non-Manual, For Endoscope2Product Code
- FERAnoscope And Accessories2Product Code
- FESRecorder, External, Pressure, Amplifier & Transducer2Product Code
- FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology2Product Code
- FFFCover, Biopsy Forceps1Product Code
- FFGDevice, Urine Flow Rate Measuring, Non-Electrical, Disposable2Product Code
- FFSImage, Illumination, Fiberoptic, For Endoscope2Product Code
- FFTElectrode, Ph, Stomach1Product Code
- K102543BRAVO PH MONITORING SYSTEM AND ACCESSORIES1Cleared 510(K)
- K013951SANDHILL SCIENTIFIC PEDIATEC PH PROBE1Cleared 510(K)
- K002028BRAVO PH MONITORING SYSTEM1Cleared 510(K)
- K961346PH ANALYSIS MODULE1Cleared 510(K)
- K950087LOT 4401Cleared 510(K)
- K955018TRIP NGS & SIGMOID CATHETER PHI SLIDE CALCULATOR1Cleared 510(K)
- K945069FLEXILOG 20001Cleared 510(K)
- K920849TRIP CIC CATHETER1Cleared 510(K)
- K934434CYBERRX MODEL 72001Cleared 510(K)
- K925405ZINETICS COMPOSITE SENSOR PROBE W/INTERNAL REF.1Cleared 510(K)
- K931963SANDHILL DISPOSABLE INTERNAL REFERENCE PH PROBE1Cleared 510(K)
- K913817MONOCRYSTANT PH-REFERENCE CATHETER, MODIFICATION1Cleared 510(K)
- K914624PH METER, MODIFICATION1Cleared 510(K)
- K912772SUPERLOGGER1Cleared 510(K)
- K913387DIGITRAPPER MARK III1Cleared 510(K)
- K911825TRIP(TM) NASOGASTRIC SUMP CATHETER1Cleared 510(K)
- K910694ZINETICS INTERNAL REFERENCE PROBE1Cleared 510(K)
- K903646GASTROGRAPH1Cleared 510(K)
- K902366MODIFIED PROXIMA MONITOR/DIGITRAPPER ED UNIT1Cleared 510(K)
- K896288FLEXILOG 1010 AMBULATORY PH MONITORING SYSTEM1Cleared 510(K)
- K883960GIPHY MONITOR1Cleared 510(K)
- K891410NASOGASTRIC PH SUCTION CATHETER, ST-50011Cleared 510(K)
- K883234TONOMITOR (TM) + SUMP1Cleared 510(K)
- K881706PROXIMA 1 PH MONITOR1Cleared 510(K)
- K874709DIAMOND MEDICAL, INC. MODEL DM 8001Cleared 510(K)
- K874710DIAMOND MEDICAL, INC. MODEL DM 6001Cleared 510(K)
- K875369MODEL ISO-2001 UNIV. PATIENT ISOLATION CIRCUIT1Cleared 510(K)
- K871921GENERAL PURPOSE COMBINATION PH ELECTRODE1Cleared 510(K)
- K871922PORTABLE PH, MV, TEMP METER W/AUTO. TEMP COMPENSA.1Cleared 510(K)
- K872929PH MONITORING SYSTEM1Cleared 510(K)
- K871282SYNECTICS LIBERTY SYSTEM AMPLIFIER AND SOFTWARE1Cleared 510(K)
- K870606TONOMITOR(TM)1Cleared 510(K)
- K863298DIAMOND MEDICAL, INC., MODEL DM 7001Cleared 510(K)
- K862727ZINETICS GASTROMETER (TM)1Cleared 510(K)
- K862929SYNECTICS MOTILITY SYSTEM1Cleared 510(K)
- K862536MODEL 1010 AMBULATORY PH MONITORING SYSTEM1Cleared 510(K)
- K854514AMBI-24 PH/PRESSURE MONITOR1Cleared 510(K)
- K853280FOUR CHANNEL PH PROBE1Cleared 510(K)
- K853648SYNECTICS LIBERTY SYS COMPRIS DIGITRAPPER MK II MO1Cleared 510(K)
- K852289MODEL SA3 ESOPHAGEAL PH ELECTRODE1Cleared 510(K)
- K850778SET -502T PH ESOPHAGEAL MICRO SIZE ELECTRODE1Cleared 510(K)
- K850361SYNECTICS PH SYS COMPRISING DIGITRAPPER MARK II, E1Cleared 510(K)
- K850074ESOPHOGEAL PH CATHETER1Cleared 510(K)
- K842690SYNECTICS PH & PRESSURE ESOPHAGEAL MONIT1Cleared 510(K)
- K841384PROXIMA 1 PH MONITOR1Cleared 510(K)
- K834512SANDMILL RMS1Cleared 510(K)
- K822815MODEL 700 GASTROREFLUX MONITOR/AMALYZER1Cleared 510(K)
- K820566PATIENT ISOLATOR #S-10/D-101Cleared 510(K)
- K811083ESOPHAGEAL MOTILITY PROBE1Cleared 510(K)
- FFXSystem, Gastrointestinal Motility (Electrical)2Product Code
- FFYAdaptor, Bulbs, Miscellaneous, For Endoscope1Product Code
- FFZCord, Electric, For Endoscope2Product Code
- FGAKit, Nephroscope2Product Code
- FGBUreteroscope And Accessories, Flexible/Rigid2Product Code
- FGCUrethroscope2Product Code
- FGSCarrier, Sponge, Endoscopic2Product Code
- FHOPneumoperitoneum Needle2Product Code
- FHPNeedle, Pneumoperitoneum, Simple2Product Code
- FHXJelly, Lubricating, For Transurethral Surgical Instrument2Product Code
- FJLResectoscope2Product Code
- FTILamp, Endoscope, Incandescent2Product Code
- FTJColonoscope, General & Plastic Surgery2Product Code
- GCFProctoscope2Product Code
- GCKGastroscope, General & Plastic Surgery2Product Code
- GCLEsophagoscope, General & Plastic Surgery2Product Code
- GCMEndoscope, Rigid2Product Code
- GCNEndoscope, Prism2Product Code
- GCOEndoscope, Mirror2Product Code
- GCPEndoscope, Ac-Powered And Accessories2Product Code
- GCQEndoscope, Flexible2Product Code
- GCSEndoscope, Battery-Powered And Accessories2Product Code
- GCTLight Source, Endoscope, Xenon Arc2Product Code
- GCWTransformer, Endoscope2Product Code
- GDBEndoscope, Fiber Optic2Product Code
- KDMSigmoidoscope, Rigid, Non-Electrical2Product Code
- KDORongeur, Cystoscopic, Hot2Product Code
- KGDScissors For Cystoscope2Product Code
- KLAMonitor, Esophageal Motility, Anorectal Motility, And Tube2Product Code
- KNWInstrument, Biopsy2Product Code
- MNKEndoscopic Bite Block1Product Code
- MNLAccessories, Cleaning Brushes, For Endoscope1Product Code
- MYESystem, Electrogastrography (Egg)2Product Code
- NBGMarker, Colon2Product Code
- NEZSystem, Imaging, Gastrointestinal, Wireless, Capsule2Product Code
- NLMLaparoscope, General & Plastic Surgery, Reprocessed2Product Code
- NLSInstrument, Biopsy, Reprocessed2Product Code
- NLXNeedle, Pneumoperitoneum, Spring Loaded, Reprocessed2Product Code
- NMXNeedle And Needle Set, Gastro-Urology, Reprocessed2Product Code
- NMYNeedle, Endoscopic, Reprocessed2Product Code
- NONForceps, Biopsy, Non-Electric, Reprocessed1Product Code
- NSISystem, Imaging, Esophageal, Wireless, Capsule2Product Code
- NTNLed Light Source2Product Code
- NWBEndoscope, Accessories, Narrow Band Spectrum2Product Code
- NYVGastrointestinal Motility System, Capsule2Product Code
- NWSKit, Choledochoscope, Flexible And Rigid2Product Code
- NWTEndoscopic Cholangiogram Kit2Product Code
- NWUEndoscope Introducer Kit2Product Code
- OCSEndoscopic Video Imaging System/Component, Gastroenterology-Urology2Product Code
- OCTAnti Fog Solution And Accessories, Endoscopy2Product Code
- OCUEndoscopic Storage Cover2Product Code
- OCVEndoscope Holder2Product Code
- OCWEndoscopic Tissue Approximation Device2Product Code
- OCXEndoscopic Irrigation/Suction System2Product Code
- OCYEndoscopic Guidewire, Gastroenterology-Urology2Product Code
- OCZEndoscopic Grasping/Cutting Instrument, Non-Powered2Product Code
- ODAEndoscopic Central Control Unit2Product Code
- ODBEndoscopic Contamination Prevention Sheath2Product Code
- ODCEndoscope Channel Accessory2Product Code
- ODDEndoscopic Retrograde Cholangiopancreatography (Ercp) Cannula2Product Code
- ODEEndoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)2Product Code
- ODFMini Endoscope, Gastroenterology-Urology2Product Code
- ODGEndoscopic Ultrasound System, Gastroenterology-Urology2Product Code
- PCVEndoscopic Leak Tester2Product Code
- PEAEndoscope, Accessories, Image Post-Processing For Color Enhancement2Product Code
- PGDColon Capsule Imaging System2Product Code
- PGUSpatial Imaging For Display Of Endoscope Position2Product Code
- PHTBasin For Endoscope Reprocessing1Product Code
- PLLSubmucosal Injection Agent2Product Code
- POZBiopsy Needle Kit2Product Code
- PPENephroscope Set2Product Code
- PRVGastro-Urology Biopsy Kit2Product Code
- PTQEndoscopic Magnetic Retriever, Exempt2Product Code
- QFZGastroenterology-Urology Accessories To A Biopsy Instrument1Product Code
- PTRScissors For Cytoscope, Exempt2Product Code
- PTSEndoscopic Grasping/Cutting Instrument, Non-Powered, Exempt2Product Code
- QIJEndoscopic Transhepatic Venous Access Needle2Product Code
- QISEsophageal, Mucosal, Electrical Characterization2Product Code
- QKZMagnetically Maneuvered Capsule Endoscopy System2Product Code
- QNPGastrointesinal Lesion Software Detection System2Product Code
- SBXSoftware For Endoscopy Procedure Metrics2Product Code
- Subpart B—Obstetrical and Gynecological Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Obstetrical and Gynecological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
SYNECTICS PH SYS COMPRISING DIGITRAPPER MARK II, E
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K850361
- 510(k) Type
- Traditional
- Applicant
- SYNECTICS-DANTEC
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/1/1985
- Days to Decision
- 91 days