Cleared Traditional

ACOUSTIC RHINOMETER

K921452 · Hood Laboratories · Anesthesiology
Jul 1993
Decision
469d
Days
Class 2
Risk

About This 510(k) Submission

K921452 is an FDA 510(k) clearance for the ACOUSTIC RHINOMETER, a Rhinoanemometer (measurement Of Nasal Decongestion) (Class II — Special Controls, product code BXQ), submitted by Hood Laboratories (Pembroke, US). The FDA issued a Cleared decision on July 8, 1993, 469 days after receiving the submission on March 26, 1992. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1800.

Submission Details

510(k) Number K921452 FDA.gov
FDA Decision Cleared SESE
Date Received March 26, 1992
Decision Date July 08, 1993
Days to Decision 469 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code BXQ — Rhinoanemometer (measurement Of Nasal Decongestion)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1800

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