Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- FLKThermometer, Clinical Mercury2Product Code
- CARMonitor, Spinal-Fluid Pressure, Electrically Powered2Product Code
- FLLThermometer, Electronic, Clinical2Product Code
- FLNMonitor, Electric For Gravity Flow Infusion Systems2Product Code
- K172242DripAssist Plus2Cleared 510(K)
- K150687DripAssist2Cleared 510(K)
- K133870FLUID LEVEL MONITOR2Cleared 510(K)
- K080704LOW FLUID ALARM2Cleared 510(K)
- K050783ISSYS DRUG FLOW MONITOR2Cleared 510(K)
- K060123LEVELERT II FLUID LEVEL SENSOR2Cleared 510(K)
- K030136DRIP ALERT2Cleared 510(K)
- K022248STRYKER L3 HYDROLERT2Cleared 510(K)
- K013121MT ALERT INFUSION MONITOR2Cleared 510(K)
- K973025FLUID CENTURION (4-100-00)2Cleared 510(K)
- K972084ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M2122Cleared 510(K)
- K923561AC-901 I.V. INFUSION DROP COUNTER2Cleared 510(K)
- K910323BEDSIDE FLUID MANAGEMENT SYSTEM 1000 (FMS-1000)2Cleared 510(K)
- K902808DRIPTROL2Cleared 510(K)
- K903193SMITH & NEPHEW DYONICS LEVELERT SYSTEM2Cleared 510(K)
- K893693H.U. I.V. DROP COUNTER2Cleared 510(K)
- K853843IV MATE2Cleared 510(K)
- K853549MCGAW/DROP WATCH FLOW MONITOR2Cleared 510(K)
- K852433INFUSAFE 205 CATOLOG NO. 205.0002Cleared 510(K)
- K850710TRAVENOL FLO-GARD 500 IV MONITOR2Cleared 510(K)
- K844309IV RATEMETER2Cleared 510(K)
- K844227INFUSART2Cleared 510(K)
- K844556KHM 2000 DRIP WATCHER2Cleared 510(K)
- K831596DROP RATE COUNTER #3402Cleared 510(K)
- K823018MODEL 460 INTERMITTENT MEDICATION DELIV2Cleared 510(K)
- K821823I.V. SENTINEL2Cleared 510(K)
- K802166MODEL AS* 7B AUTOSYRINGE INFUSION PUMP2Cleared 510(K)
- K802011INFUSSION ALARM SYSTEM I.A.S. CAT.#11182Cleared 510(K)
- K801734IMED DROP RATE CALCULATOR #3402Cleared 510(K)
- K802101I.V. SENTRY ALARM DEVICE2Cleared 510(K)
- K790836GUARDIAN II I.V. CONTROLLER2Cleared 510(K)
- K790669DROP CONTROLLER2Cleared 510(K)
- K781589VOLUMETRIC CONTROLLER MODEL 3102Cleared 510(K)
- K781717MONITOR, GRAVITY IRRIGATION DRIP2Cleared 510(K)
- K781297INTRA-ALERT2Cleared 510(K)
- K780223PARENTERAL INFUSION CONTROLLER2Cleared 510(K)
- K780106PARENTERAL INFUSION CONTROLLER, ELEC.2Cleared 510(K)
- K760931I.V. DRIP MONITOR ALARM DEVICE, MONIFLO2Cleared 510(K)
- K760694ARNCO I.V. MONITOR2Cleared 510(K)
- FMJManometer, Spinal-Fluid2Product Code
- FQAScale, Surgical Sponge1Product Code
- FQZThermometer, Clinical Color Change1Product Code
- FRCIndicator, Biological Sterilization Process2Product Code
- FRIScale, Stand-On, Patient1Product Code
- FRWScale, Patient1Product Code
- JOJIndicator, Physical/Chemical Sterilization Process2Product Code
- KMIMonitor, Bed Patient1Product Code
- KPDStrip, Temperature, Forehead, Liquid Crystal2Product Code
- LHBTimer, Apgar1Product Code
- LRTIndicator, Sterilization2Product Code
- MRBIndicator, Biological, Liquid Chemical Sterilization Process2Product Code
- MRLScale, Sponge, Surgical, Electrically-Powered1Product Code
- MTCIndicator, Chemical, Enzymatic, Sterilization Process2Product Code
- OCIIndicator, Physical/Chemical, Storage Temperature2Product Code
- OZKThermometer, Exhaled Breath2Product Code
- PJOFall Prevention Alarm/Sensor Combination Attached Or Unattached1Product Code
- PJPFall Prevention Alarm/Sensor Attached Only1Product Code
- PWWFever Monitoring Kit2Product Code
- PXHThermometer Kit2Product Code
- QKMA Chemical Vapor Sterilization Multivariable Chemical Indicator2Product Code
- SBOBed-Patient Activity Monitoring System1Product Code
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic 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
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- 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
GUARDIAN II I.V. CONTROLLER
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K790836
- 510(k) Type
- Traditional
- Applicant
- CENTAUR SCIENCES, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/30/1979
- Days to Decision
- 91 days