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
- 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
- K141877LEAF PATIENT MONITORING SYSTEM1Cleared 510(K)
- K131585INTEL-GE CARE INNOVATIONS QUIETCARE1Cleared 510(K)
- K130752DYNASENSE SYSTEM1Cleared 510(K)
- K101109VIVATRAK1Cleared 510(K)
- K090138MOBILECARE MONITOR, MODEL 21001Cleared 510(K)
- K942770ULTIMAT-SENSOR FOR BED OCCUPANCY MONITOR1Cleared 510(K)
- K943481INFORMER PLUS1Cleared 510(K)
- K933552PM-PAGER1Cleared 510(K)
- K934344HOME AMB-ALERT1Cleared 510(K)
- K940405TELETOM1Cleared 510(K)
- K924433SENIOR TECH TABS 88 TRANS RA1/WRA1/R1 ANN TYPE CR11Cleared 510(K)
- K925529WANDER CARE1Cleared 510(K)
- K920206POSEY SITTER1Cleared 510(K)
- K914859BARTRONIX IN-BED ACTIVITY MONITOR1Cleared 510(K)
- K911079AMB-ALERT1Cleared 510(K)
- K905586RSVP RF-20001Cleared 510(K)
- K905421EXIT ALARM1Cleared 510(K)
- K901969ALERT BED ALARM SYSTEM1Cleared 510(K)
- K901330THE MONITOR ELECTRONIC BED ALARM SYSTEM1Cleared 510(K)
- K883390PMD SYSTEM-201Cleared 510(K)
- K873806JDM SP2 SENSOR1Cleared 510(K)
- K872358STA-PUT1Cleared 510(K)
- K871203BED PATIENT PRESENCE MONITOR1Cleared 510(K)
- K864827RSVP SYSTEMS, SERIES I, BED-PATIENT MONITOR1Cleared 510(K)
- K860537THE CELL CARE SYSTEM1Cleared 510(K)
- K854950BED PATIENT MONITOR1Cleared 510(K)
- K841671FALL-SAFE MONITOR1Cleared 510(K)
- K841672FALL-SAFE VEST1Cleared 510(K)
- K840295AMBULARM1Cleared 510(K)
- K823926BED-CHECK: II-IFAC1Cleared 510(K)
- K770695MONITOR, BED, TECHNOLICS1Cleared 510(K)
- 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
AMBULARM
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K840295
- 510(k) Type
- Traditional
- Applicant
- RIGI SYSTEMS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/7/1984
- Days to Decision
- 104 days