Question 1

Who is the manufacturer of THE MONITOR MODEL MI-1.2.3 TONE COUNT SCREEN AUDIO?

Accepted Answer

Monitor Instruments, Inc. filed the 510(k) submission for THE MONITOR MODEL MI-1.2.3 TONE COUNT SCREEN AUDIO (K922383).

Question 2

What is the FDA product code for THE MONITOR MODEL MI-1.2.3 TONE COUNT SCREEN AUDIO?

Accepted Answer

EWO. It is classified under 21 CFR 874.1050 as a Class 2 device in the Ear, Nose, Throat panel.

Question 3

When was THE MONITOR MODEL MI-1.2.3 TONE COUNT SCREEN AUDIO cleared by the FDA?

Accepted Answer

Jan 15, 1993 (decision: SESE).

Question 4

What is the regulatory pathway for THE MONITOR MODEL MI-1.2.3 TONE COUNT SCREEN AUDIO?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like THE MONITOR MODEL MI-1.2.3 TONE COUNT SCREEN AUDIO?

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	K922383
Device Name	THE MONITOR MODEL MI-1.2.3 TONE COUNT SCREEN AUDIO
Applicant	Monitor Instruments, Inc.
Product Code	EWO · Ear, Nose, Throat
Decision Date	Jan 15, 1993
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 874.1050
Device Class	Class 2

THE MONITOR MODEL MI-1.2.3 TONE COUNT SCREEN AUDIO

Device Facts

Regulatory Classification

Identification