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510(k) K921452

ACOUSTIC RHINOMETER by Hood Laboratories — Product Code BXQ

K921452 is an FDA 510(k) premarket notification submitted by Hood Laboratories for the device "ACOUSTIC RHINOMETER". The FDA issued a decision of Substantially Equivalent on July 8, 1993. The device falls under product code BXQ (Rhinoanemometer (Measurement Of Nasal Decongestion)), a Class II device regulated under 21 CFR 868.1800. Hood Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 1993
Date Received
March 26, 1992
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 Hood Laboratories

  • K920994 — HOOD NASAL SEPTAL BUTTON (May 15, 1992)
  • K905703 — KRUPIN EYE VALVE WITH DISK (March 15, 1991)
  • K904821 — ELIACHAR MODIFIED ESOPHAGEAL STENT (January 14, 1991)
  • K897049 — GIBSON ENDOLYMPHATIC SHUNT (March 16, 1990)
  • K897059 — HOOD SPEAKING VALVE (March 12, 1990)
  • K893866 — HOOD PEDIATRIC TRACHEOSTOMY TUBE (August 7, 1989)
  • K884810 — SILICONE LARYNGEAL STENT (May 10, 1989)
  • K890599 — HOOD NASAL SPLINT (March 17, 1989)
  • K885125 — KRUPIN EYE VALVE W/SCLERAL BUCKLE (January 24, 1989)
  • K882430 — HOOD TRACHEAL STOMA BUTTON (June 28, 1988)

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)
  • 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