Anesthesiology
Review Panel
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- ChemistryReview Panel
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- 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
- KPDStrip, Temperature, Forehead, Liquid Crystal2Product Code
- K934941E-Z TEMP II2Cleared 510(K)
- K903307TEMP MARQ TEMPERATURE TREND INDICATOR2Cleared 510(K)
- K893803FEVER LINE AND FEVER LINE PLUS2Cleared 510(K)
- K864853OMNI THERM TEMPERATURE MONITOR2Cleared 510(K)
- K850797TEMPALERT LIQUID CRYSTAL THERMOMETER2Cleared 510(K)
- K841913TEMPTREND PEDS AXILLARY TEMP. INDICATOR2Cleared 510(K)
- K833904TEMPTREND II2Cleared 510(K)
- K832651ATI FOREHEAD THERMOMETER2Cleared 510(K)
- K823221ACCA-TEMP SKIN TEMP. VINYL DISC2Cleared 510(K)
- K821312TEMPTREND TEMPERATURE TREND INDICATOR2Cleared 510(K)
Show All 21 Submissions
- 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
TEMPTREND PEDS AXILLARY TEMP. INDICATOR
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K841913
- 510(k) Type
- Traditional
- Applicant
- BIOSYNERGY, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/2/1984
- Days to Decision
- 177 days