Who is the manufacturer of CONSTANT CURRENT STIMULATOR MODEL 022101?

Ep Technologies, Inc. filed the 510(k) submission for CONSTANT CURRENT STIMULATOR MODEL 022101 (K900553).

What is the FDA product code for CONSTANT CURRENT STIMULATOR MODEL 022101?

JOQ. It is classified under 21 CFR 870.1750 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for CONSTANT CURRENT STIMULATOR MODEL 022101?

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

Who can help prepare an FDA 510(k) submission like CONSTANT CURRENT STIMULATOR MODEL 022101?

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.

CONSTANT CURRENT STIMULATOR MODEL 022101

K900553 · Ep Technologies, Inc. · JOQ · Mar 13, 1990 · Cardiovascular

Device Facts

Record ID	K900553
Device Name	CONSTANT CURRENT STIMULATOR MODEL 022101
Applicant	Ep Technologies, Inc.
Product Code	JOQ · Cardiovascular
Decision Date	Mar 13, 1990
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1750
Device Class	Class 2

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