Question 1

Who is the manufacturer of ECCOVISION ACOUSTIC DIAGNOSTIC IMAGING ACOUSTIC PHARYNGOMETER?

Accepted Answer

E. Benson Hood Lab, Inc. filed the 510(k) submission for ECCOVISION ACOUSTIC DIAGNOSTIC IMAGING ACOUSTIC PHARYNGOMETER (K011329).

Question 2

What is the FDA product code for ECCOVISION ACOUSTIC DIAGNOSTIC IMAGING ACOUSTIC PHARYNGOMETER?

Accepted Answer

BXQ. It is classified under 21 CFR 868.1800 as a Class 2 device in the Anesthesiology panel.

Question 3

When was ECCOVISION ACOUSTIC DIAGNOSTIC IMAGING ACOUSTIC PHARYNGOMETER cleared by the FDA?

Accepted Answer

Jul 26, 2002 (decision: SESE).

Question 4

What is the regulatory pathway for ECCOVISION ACOUSTIC DIAGNOSTIC IMAGING ACOUSTIC PHARYNGOMETER?

Accepted Answer

510(k) clearance (submission type: Traditional).

Question 5

Who can help prepare an FDA 510(k) submission like ECCOVISION ACOUSTIC DIAGNOSTIC IMAGING ACOUSTIC PHARYNGOMETER?

Accepted Answer

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Record ID	K011329
Device Name	ECCOVISION ACOUSTIC DIAGNOSTIC IMAGING ACOUSTIC PHARYNGOMETER
Applicant	E. Benson Hood Lab, Inc.
Product Code	BXQ · Anesthesiology
Decision Date	Jul 26, 2002
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1800
Device Class	Class 2

ECCOVISION ACOUSTIC DIAGNOSTIC IMAGING ACOUSTIC PHARYNGOMETER

Device Facts

Regulatory Classification

Identification