Question 1

Who is the manufacturer of NEUROTRAC?

Accepted Answer

Hdc Corp. filed the 510(k) submission for NEUROTRAC (K831715).

Question 2

What is the FDA product code for NEUROTRAC?

Accepted Answer

ETN. It is classified under 21 CFR 874.1820 as a Class 2 device in the Ear, Nose, Throat panel.

Question 3

When was NEUROTRAC cleared by the FDA?

Accepted Answer

Jul 7, 1983 (decision: SESE).

Question 4

What is the regulatory pathway for NEUROTRAC?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like NEUROTRAC?

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	K831715
Device Name	NEUROTRAC
Applicant	Hdc Corp.
Product Code	ETN · Ear, Nose, Throat
Decision Date	Jul 7, 1983
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 874.1820
Device Class	Class 2

NEUROTRAC

Device Facts

Regulatory Classification

Identification