Question 1

Who is the manufacturer of NARCOTRACE 80?

Accepted Answer

Narco Scientific filed the 510(k) submission for NARCOTRACE 80 (K830338).

Question 2

What is the FDA product code for NARCOTRACE 80?

Accepted Answer

DXN. It is classified under 21 CFR 870.1130 as a Class 2 device in the Cardiovascular panel.

Question 3

When was NARCOTRACE 80 cleared by the FDA?

Accepted Answer

Dec 22, 1983 (decision: SESE).

Question 4

What is the regulatory pathway for NARCOTRACE 80?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like NARCOTRACE 80?

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	K830338
Device Name	NARCOTRACE 80
Applicant	Narco Scientific
Product Code	DXN · Cardiovascular
Decision Date	Dec 22, 1983
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1130
Device Class	Class 2

NARCOTRACE 80

Device Facts

Regulatory Classification

Identification