Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart C—Microbiology DevicesCFR Sub-Part
- Subpart D—Clinical Toxicology Test SystemsCFR Sub-Part
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart D—Serological ReagentsCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- QFGAlternate Controller Enabled Insulin Infusion Pump2Product Code
- LZFPump, Infusion, Analytical Sampling2Product Code
- K192785OptiScanner® 5000 Glucose Monitoring System2Cleared 510(K)
- K162042OptiScanner 5000 Glucose Monitoring System2Cleared 510(K)
- K011238RODA (REAL TIME OXYGEN DYNAMICS ANALYSIS) MONITORING SYSTEM2Cleared 510(K)
- K951739PUMP/BLOOD CHEMISTRY MONITOR2Cleared 510(K)
- K922997VIA 1-01 INFUSION PUMP/BLOOD CHEM. SYST. -- MOD.2Cleared 510(K)
- K920438VIA 1-01 INFUSION PUMP BLOOD CHEMISTRY SYSTEM2Cleared 510(K)
- K882830INFUSION PUMP2Cleared 510(K)
- LZGPump, Infusion, Insulin2Product Code
- Subpart F—Immunological Test SystemsCFR Sub-Part
- 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
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
OptiScanner® 5000 Glucose Monitoring System
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K192785
- 510(k) Type
- Traditional
- Applicant
- Optiscan Biomedical Corporation
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/5/2020
- Days to Decision
- 128 days
- Submission Type
- Summary