FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

FDA 510(k) Search

K Number

K011329

Device Name

ECCOVISION ACOUSTIC DIAGNOSTIC IMAGING ACOUSTIC PHARYNGOMETER

Manufacturer

E. BENSON HOOD LAB, INC.

Date Cleared

2002-07-26

(451 days)

Product Code

BXQ

Regulation Number

868.1800

Intended Use

Device Description

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

N/A

Reference Devices

N/A

AI/ML (Artificial Intelligence / Machine Learning)

N/A

Therapeutic

N/A

Diagnostic

N/A

SaMD (Software as a Medical Device)

N/A

IVD (In Vitro Diagnostic)

N/A

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

N/A

Regulation Number and Section

§ 868.1800 Rhinoanemometer.

(a)
Identification. A rhinoanemometer is a device used to quantify the amount of nasal congestion by measuring the airflow through, and differential pressure across, a patient's nasal passages.(b)
Classification. Class II (performance standards).

Summary

N/A