Question 1

Who is the manufacturer of JCM LABS CUSTOM PRESCRIPTION & ACCENT IN-THE-EAR?

Accepted Answer

Jcm Labs, Inc. filed the 510(k) submission for JCM LABS CUSTOM PRESCRIPTION & ACCENT IN-THE-EAR (K844093).

Question 2

What is the FDA product code for JCM LABS CUSTOM PRESCRIPTION & ACCENT IN-THE-EAR?

Accepted Answer

ESD. It is classified under 21 CFR 874.3300 as a Class 1 device in the Ear, Nose, Throat panel.

Question 3

When was JCM LABS CUSTOM PRESCRIPTION & ACCENT IN-THE-EAR cleared by the FDA?

Accepted Answer

Jan 29, 1985 (decision: SESE).

Question 4

What is the regulatory pathway for JCM LABS CUSTOM PRESCRIPTION & ACCENT IN-THE-EAR?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like JCM LABS CUSTOM PRESCRIPTION & ACCENT IN-THE-EAR?

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	K844093
Device Name	JCM LABS CUSTOM PRESCRIPTION & ACCENT IN-THE-EAR
Applicant	Jcm Labs, Inc.
Product Code	ESD · Ear, Nose, Throat
Decision Date	Jan 29, 1985
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 874.3300
Device Class	Class 1

JCM LABS CUSTOM PRESCRIPTION & ACCENT IN-THE-EAR

Device Facts

Regulatory Classification

Identification