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
- NDCCalculator, Drug Dose2Product Code
- 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)
Show All 45 Submissions
- 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
- 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
iSage Rx
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K242066
- 510(k) Type
- Traditional
- Applicant
- Amalgam Rx, Inc
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/21/2024
- Days to Decision
- 37 days
- Submission Type
- Summary