Anesthesiology
Review Panel
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- MiscellaneousMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- NDCCalculator, Drug Dose2Product Code
- K252104T1D12Cleared 510(K)
- K241088EndoTool IV (3.1)2Cleared 510(K)
- K242775InPen System App (MMT-8060 (iOS), MMT-8061 (Android))2Cleared 510(K)
- K242066iSage Rx2Cleared 510(K)
- K232451Insulia Bolus Companion2Cleared 510(K)
- K230813BlueStar and BlueStar Rx2Cleared 510(K)
- K221924Digital Routines2Cleared 510(K)
- K211160EndoTool SubQ 2.12Cleared 510(K)
- K203434BlueStar Rx2Cleared 510(K)
- K202596Insulia Diabetes Management Companion2Cleared 510(K)
- K201619EndoTool IV System2Cleared 510(K)
- K201337InPen System2Cleared 510(K)
- K200443EndoTool IV 1.102Cleared 510(K)
- K190487InPen Dose Calculator2Cleared 510(K)
- K192841InPen System2Cleared 510(K)
- K181916d-Nav System2Cleared 510(K)
- K180366EndoTool SubQ2Cleared 510(K)
- K181327InPen Dose Calculator2Cleared 510(K)
- K171450Glooko Mobile Insulin Dosing System2Cleared 510(K)
- K172177Insulia Diabetes Management Companion2Cleared 510(K)
- K163664Health-e-Connect System with IDA2Cleared 510(K)
- K152300Glucommander2Cleared 510(K)
- K170669Insulia Diabetes Management Companion2Cleared 510(K)
- K160673Insulin Algorithms System2Cleared 510(K)
- K171230My Dose Coach2Cleared 510(K)
- K163099My Dose Coach2Cleared 510(K)
- K161865iSage Rx (iSage Rx Basal Insulin Titration)2Cleared 510(K)
- K160949Go Dose System2Cleared 510(K)
- K161433Insulia Diabetes Management Companion2Cleared 510(K)
- K150910ACCU-CHEK Connect Diabetes Management App2Cleared 510(K)
- K142918EndoTool SubQ2Cleared 510(K)
- K141929ACCU-CHEK CONNECT DIABETES MANAGEMENT APP2Cleared 510(K)
- K142123REACH ACCESS TELEMEDICINE DOSE CALCULATOR2Cleared 510(K)
- K141321GLUCOSTABILIZER INSULIN DOSING CALCULATOR2Cleared 510(K)
- K132547ENDO TOOL GLUCOSE MANAGEMENT SYSTEM (EGMS)2Cleared 510(K)
- K121542PICIS WEIGHT BASED DOSE CONVERTER2Cleared 510(K)
- K113853G+ SYSTEM2Cleared 510(K)
- K101344G+ SYSTEM2Cleared 510(K)
- K082512INTELLIGENT DOSING SYSTEM FOR INSULIN-MY INSULIN DOSER2Cleared 510(K)
- K081388GLUCOCARE INTENSIVE GLYCEMIC CONTROL SYSTEM2Cleared 510(K)
- K071713CLARIAN GLUCOSE STABILIZER INSULIN DOSING CALCULATOR2Cleared 510(K)
- K053137ENDOTOOL DRUG DOSE CALCULATOR2Cleared 510(K)
- K061110GLUCOMMANDER PLUS2Cleared 510(K)
- K043529ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE2Cleared 510(K)
- K011571TRXF INTELLIGENT DOSING SYSTEM (IDS) -DOSING CALCULATOR SUITE2Cleared 510(K)
- K000418PDT DOSECALCULATOR, MODEL 800002Cleared 510(K)
- 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
- Subpart F—Immunological Test SystemsCFR Sub-Part
- DentalReview Panel
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- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
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- General and Plastic SurgeryReview Panel
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- Medical GeneticsReview Panel
- UnknownReview Panel
InPen System
- Page Type
- Cleared 510(K)
- 510(k) Number
- K201337
- 510(k) Type
- Special
- Applicant
- Companion Medical, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/18/2020
- Days to Decision
- 29 days
- Submission Type
- Summary