Question 1

Who is the manufacturer of ELECTRODE CABLE?

Accepted Answer

Vital Connections, Inc. filed the 510(k) submission for ELECTRODE CABLE (K880320).

Question 2

What is the FDA product code for ELECTRODE CABLE?

Accepted Answer

DSA. It is classified under 21 CFR 870.2900 as a Class 2 device in the Cardiovascular panel.

Question 3

When was ELECTRODE CABLE cleared by the FDA?

Accepted Answer

Mar 22, 1988 (decision: SESE).

Question 4

What is the regulatory pathway for ELECTRODE CABLE?

Accepted Answer

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

Question 5

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

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	K880320
Device Name	ELECTRODE CABLE
Applicant	Vital Connections, Inc.
Product Code	DSA · Cardiovascular
Decision Date	Mar 22, 1988
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.2900
Device Class	Class 2

ELECTRODE CABLE

Device Facts

Regulatory Classification

Identification