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510(k) K853024

RHINOTEST MP by Intertronic, Inc. — Product Code BXQ

K853024 is an FDA 510(k) premarket notification submitted by Intertronic, Inc. for the device "RHINOTEST MP". The FDA issued a decision of Substantially Equivalent on September 27, 1985. The device falls under product code BXQ (Rhinoanemometer (Measurement Of Nasal Decongestion)), a Class II device regulated under 21 CFR 868.1800.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1985
Date Received
July 18, 1985
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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  • K022311 — RHINOSTREAM RHINOMANOMETER MODULE (October 4, 2002)
  • 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)
  • K851143 — RHINOMANOMETERS NR3, NR4 (May 23, 1985)

FDA data resources