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510(k) K972140

A1 ACOUSTIC RHINOMETER by G.M. Instruments , Ltd. — Product Code BXQ

K972140 is an FDA 510(k) premarket notification submitted by G.M. Instruments , Ltd. for the device "A1 ACOUSTIC RHINOMETER". The FDA issued a decision of Substantially Equivalent on September 30, 1998. The device falls under product code BXQ (Rhinoanemometer (Measurement Of Nasal Decongestion)), a Class II device regulated under 21 CFR 868.1800.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 1998
Date Received
June 6, 1997
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

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FDA data resources