VISIONAIR

510(k)K221892AnesthesiologyBXQ

PacificMD Biotech Llc is listed for VISIONAIR (K221892). The FDA list gives October 5, 2022 as the date of the final decision. The lead panel is Anesthesiology, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is BXQ. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K221892

Official FDA database record

Date of final decision: October 5, 2022
Company on the FDA list: PacificMD Biotech Llc
Lead panel: Anesthesiology
Primary product code: BXQ
openFDA device name for the code: Rhinoanemometer (Measurement Of Nasal Decongestion)
Device class: 2
Regulation number: 868.1800
openFDA decision description: Substantially Equivalent
openFDA decision code: SESE
Statement or summary label: Summary