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510(k) K851143

RHINOMANOMETERS NR3, NR4 by And/Or Corp. — Product Code BXQ

K851143 is an FDA 510(k) premarket notification submitted by And/Or Corp. for the device "RHINOMANOMETERS NR3, NR4". The FDA issued a decision of Substantially Equivalent on May 23, 1985. The device falls under product code BXQ (Rhinoanemometer (Measurement Of Nasal Decongestion)), a Class II device regulated under 21 CFR 868.1800. And/Or Corp. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1985
Date Received
March 21, 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

Other clearances by And/Or Corp.

  • K862026 — HA-2000 REAL EAR SPECTROSCOPE (August 15, 1986)

Other clearances for product code BXQ

  • K221892 — VISIONAIR (October 5, 2022)
  • K170071 — SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS ECCOVISIONTM Rh (November 9, 2017)
  • 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)
  • K853024 — RHINOTEST MP (September 27, 1985)

FDA data resources