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510(k) K022311

RHINOSTREAM RHINOMANOMETER MODULE by Rhino Metrics A/S — Product Code BXQ

K022311 is an FDA 510(k) premarket notification submitted by Rhino Metrics A/S for the device "RHINOSTREAM RHINOMANOMETER MODULE". The FDA issued a decision of Substantially Equivalent on October 4, 2002. The device falls under product code BXQ (Rhinoanemometer (Measurement Of Nasal Decongestion)), a Class II device regulated under 21 CFR 868.1800. Rhino Metrics A/S has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 2002
Date Received
July 17, 2002
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

Other clearances by Rhino Metrics A/S

  • K000406 — RHINOSCAN MODEL SRE2000/ SRE2100 WITH ACOUSTIC RHINOMETRY MODULE (April 17, 2000)

Other clearances for product code BXQ

  • K221892 — VISIONAIR (October 5, 2022)
  • K170071 — SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS ECCOVISIONTM Rh (November 9, 2017)
  • K011329 — ECCOVISION ACOUSTIC DIAGNOSTIC IMAGING ACOUSTIC PHARYNGOMETER (July 26, 2002)
  • K000406 — RHINOSCAN MODEL SRE2000/ SRE2100 WITH ACOUSTIC RHINOMETRY MODULE (April 17, 2000)
  • K972140 — A1 ACOUSTIC RHINOMETER (September 30, 1998)
  • K921452 — ACOUSTIC RHINOMETER (July 8, 1993)
  • K902120 — MERCURY RHINOMANOMETER (August 6, 1990)
  • K896263 — RHINOMANOMETER (April 16, 1990)
  • K853024 — RHINOTEST MP (September 27, 1985)
  • K851143 — RHINOMANOMETERS NR3, NR4 (May 23, 1985)

FDA data resources