Eccovision Acoustic Diagnostic Imaging Acoustic Pharyngometer

FDA 510(k) K011329 · E. Benson Hood Lab, Inc.

Substantially Equivalent

510(k) numberK011329

Submission

Device name
Eccovision Acoustic Diagnostic Imaging Acoustic Pharyngometer
Applicant
E. Benson Hood Lab, Inc.
Pembroke, MA, US
Received
May 1, 2001
Decision date
July 26, 2002
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
BXQ – Rhinoanemometer (Measurement Of Nasal Decongestion)
Device class
Class II (moderate risk)
Regulation
21 CFR 868.1800
Specialty
Anesthesiology

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Questions and answers

When was Eccovision Acoustic Diagnostic Imaging Acoustic Pharyngometer cleared by the FDA?

Eccovision Acoustic Diagnostic Imaging Acoustic Pharyngometer (K011329) received a 510(k) decision of Substantially Equivalent on July 26, 2002, 451 days after the submission was received.

What is the product code of K011329?

The FDA product code is BXQ – Rhinoanemometer (Measurement Of Nasal Decongestion), a Class II (moderate risk) device regulated under 21 CFR 868.1800.