Question 1

Who is the manufacturer of VALLEYLAB RETURN ELECTRODE MONITOR?

Accepted Answer

Valleylab, Inc. filed the 510(k) submission for VALLEYLAB RETURN ELECTRODE MONITOR (K801153).

Question 2

What is the FDA product code for VALLEYLAB RETURN ELECTRODE MONITOR?

Accepted Answer

GEI. It is classified under 21 CFR 878.4400 as a Class 2 device in the General, Plastic Surgery panel.

Question 3

When was VALLEYLAB RETURN ELECTRODE MONITOR cleared by the FDA?

Accepted Answer

May 20, 1980 (decision: SESE).

Question 4

What is the regulatory pathway for VALLEYLAB RETURN ELECTRODE MONITOR?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like VALLEYLAB RETURN ELECTRODE MONITOR?

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	K801153
Device Name	VALLEYLAB RETURN ELECTRODE MONITOR
Applicant	Valleylab, Inc.
Product Code	GEI · General, Plastic Surgery
Decision Date	May 20, 1980
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2

VALLEYLAB RETURN ELECTRODE MONITOR

Device Facts

Regulatory Classification

Identification