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510(k) K221892

VISIONAIR by Pacificmd Biotech, LLC — Product Code BXQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 2022
Date Received
June 29, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rhinoanemometer (Measurement Of Nasal Decongestion)
Device Class
Class II
Regulation Number
868.1800
Review Panel
AN
Submission Type

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  • K000406 — RHINOSCAN MODEL SRE2000/ SRE2100 WITH ACOUSTIC RHINOMETRY MODULE (April 17, 2000)
  • K972140 — A1 ACOUSTIC RHINOMETER (September 30, 1998)
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  • K902120 — MERCURY RHINOMANOMETER (August 6, 1990)
  • K896263 — RHINOMANOMETER (April 16, 1990)
  • K853024 — RHINOTEST MP (September 27, 1985)
  • K851143 — RHINOMANOMETERS NR3, NR4 (May 23, 1985)