Question 1

Who is the manufacturer of AS 30/TCP MODULE?

Accepted Answer

Narco Scientific filed the 510(k) submission for AS 30/TCP MODULE (K831460).

Question 2

What is the FDA product code for AS 30/TCP MODULE?

Accepted Answer

KLK. It is classified under 21 CFR 868.2500 as a Class 2 device in the Anesthesiology panel.

Question 3

When was AS 30/TCP MODULE cleared by the FDA?

Accepted Answer

Jul 12, 1983 (decision: SESE).

Question 4

What is the regulatory pathway for AS 30/TCP MODULE?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like AS 30/TCP MODULE?

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	K831460
Device Name	AS 30/TCP MODULE
Applicant	Narco Scientific
Product Code	KLK · Anesthesiology
Decision Date	Jul 12, 1983
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.2500
Device Class	Class 2

AS 30/TCP MODULE

Device Facts

Regulatory Classification

Identification

Special Controls