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510(k) K011329

ECCOVISION ACOUSTIC DIAGNOSTIC IMAGING ACOUSTIC PHARYNGOMETER by E. Benson Hood Lab, Inc. — Product Code BXQ

K011329 is an FDA 510(k) premarket notification submitted by E. Benson Hood Lab, Inc. for the device "ECCOVISION ACOUSTIC DIAGNOSTIC IMAGING ACOUSTIC PHARYNGOMETER". The FDA issued a decision of Substantially Equivalent on July 26, 2002. The device falls under product code BXQ (Rhinoanemometer (Measurement Of Nasal Decongestion)), a Class II device regulated under 21 CFR 868.1800. E. Benson Hood Lab, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 2002
Date Received
May 1, 2001
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 E. Benson Hood Lab, Inc.

  • K000154 — ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1 (March 29, 2000)
  • K974132 — VOICE MASTER PROSTHESIS (February 25, 1998)

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)
  • 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