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510(k) K902120

MERCURY RHINOMANOMETER by Life-Tech Intl., Inc. — Product Code BXQ

K902120 is an FDA 510(k) premarket notification submitted by Life-Tech Intl., Inc. for the device "MERCURY RHINOMANOMETER". The FDA issued a decision of Substantially Equivalent on August 6, 1990. The device falls under product code BXQ (Rhinoanemometer (Measurement Of Nasal Decongestion)), a Class II device regulated under 21 CFR 868.1800. Life-Tech Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 1990
Date Received
May 11, 1990
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 Life-Tech Intl., Inc.

  • K001129 — PROLONG, MODELS PL50, PL100, PL150 (July 6, 2000)
  • K954505 — EZ STIM (December 10, 1996)
  • K955031 — MAXISTIM (December 10, 1996)
  • K954315 — PVC ABDOMINAL/RECTAL PRESSURE CATHETER (November 30, 1995)
  • K954341 — URODYNAMICS TUBING AND INFUSION SETS (October 17, 1995)
  • K953451 — UROPUMP TUBE & DAMPING CHAMGER (October 5, 1995)
  • K953353 — UROVISION JANUS (September 8, 1995)
  • K946108 — EAR-A-GATOR (June 13, 1995)
  • K913601 — MICROPHOR (July 15, 1994)
  • K940203 — TRIPLE LUMEN URODYNAMIC CATHETER WITH RADIOPAQUE MARKERS (March 30, 1994)

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)
  • K896263 — RHINOMANOMETER (April 16, 1990)
  • K853024 — RHINOTEST MP (September 27, 1985)
  • K851143 — RHINOMANOMETERS NR3, NR4 (May 23, 1985)

FDA data resources