Who is the manufacturer of PACE-1A CARDIAC STIMULATOR?

Radionics, Inc. filed the 510(k) submission for PACE-1A CARDIAC STIMULATOR (K963579).

What is the FDA product code for PACE-1A CARDIAC STIMULATOR?

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

What is the regulatory pathway for PACE-1A CARDIAC STIMULATOR?

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

Who can help prepare an FDA 510(k) submission like PACE-1A CARDIAC STIMULATOR?

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.

PACE-1A CARDIAC STIMULATOR

K963579 · Radionics, Inc. · JOQ · Nov 8, 1996 · Cardiovascular

Device Facts

Record ID	K963579
Device Name	PACE-1A CARDIAC STIMULATOR
Applicant	Radionics, Inc.
Product Code	JOQ · Cardiovascular
Decision Date	Nov 8, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1750
Device Class	Class 2

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