Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- Biological StainsCFR Sub-Part
- Clinical Chemistry Test SystemsCFR Sub-Part
- Clinical Laboratory InstrumentsCFR Sub-Part
- Clinical Toxicology Test SystemsCFR Sub-Part
- Diagnostic DevicesCFR Sub-Part
- NDCCalculator, Drug Dose2Product Code
- 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)
- Show All 38 Submissions
- General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Immunological Test SystemsCFR Sub-Part
- Microbiology DevicesCFR Sub-Part
- MiscellaneousMiscellaneous
- Pathology Instrumentation and AccessoriesCFR 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
d-Nav System
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K181916
- 510(k) Type
- Traditional
- Applicant
- Hygieia, Inc
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/4/2019
- Days to Decision
- 202 days
- Submission Type
- Summary