Zoll PD2000 Pacemaker/Advisory Defibrillator, Model PD2000, Zoll D2000 Advisory Defibrillator, Model D2000

Q: What is the product code of K950856?

The FDA product code is DRO – Pacemaker, Cardiac, External Transcutaneous (Non-Invasive), a Class II (moderate risk) device regulated under 21 CFR 870.5550.

FDA 510(k) K950856 · Zoll Medical Corp

Substantially Equivalent

510(k) numberK950856

Submission

Device name: Zoll PD2000 Pacemaker/Advisory Defibrillator, Model PD2000, Zoll D2000 Advisory Defibrillator, Model D2000
Applicant: Zoll Medical Corp
Burlington, MA, US
Received: February 27, 1995
Decision date: December 29, 1995
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: DRO – Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
Device class: Class II (moderate risk)
Regulation: 21 CFR 870.5550
Specialty: Cardiovascular
Life-sustaining: Yes

Other 510(k)s with product code DRO

510(k)	Device	Applicant	Decision
K012404	K-Defib/Pace Adult Electrode, Model KDP-85DRO · Traditional	Katecho, Inc.	10/12/2001SE
K012218	Ludlow Gradient Edge Adult & Pediatric Multifunctional ElectrodesDRO · Traditional	The Ludlow Company LP	10/12/2001SE
K000660	Escort Ii+ 400 Series (Escort Prism), Model 20400, 20401, 20403, Monitor, Models 20411…DRO · Special	Medical Data Electronics	03/28/2000SE
K983232	Padtak Pediatric Defib/Cardiovert/Pace/Monitor-Radiotransparent (2X2.25),MODEL 2602…DRO · Traditional	Tz Medical, Inc.	09/15/1999SE
K983196	Padtak Pace/Defib/Cardiovert Monitoring Electrode(S)DRO · Traditional	Tz Medical, Inc.	09/15/1999SE
K974034	Portable Intensive Care UnitDRO · Traditional	Medical Research Laboratories, Inc.	03/02/1998SE
K962547	Cardioserv PDRO · Traditional	Marquette Electronics, Inc.	03/06/1997SE
K963120	Responder 2500 Defibrillator and Cardiac Care SystemDRO · Traditional	Marquette Electronics, Inc.	02/28/1997SE
K961138	Esort II + 400 Series MonitorDRO · Traditional	Medical Data Electronics	12/10/1996SE
K951593	Lifepak 11DRO · Traditional	Physio-Control Corp.	12/29/1995SE

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Questions and answers

When was Zoll PD2000 Pacemaker/Advisory Defibrillator, Model PD2000, Zoll D2000 Advisory Defibrillator, Model D2000 cleared by the FDA?

Zoll PD2000 Pacemaker/Advisory Defibrillator, Model PD2000, Zoll D2000 Advisory Defibrillator, Model D2000 (K950856) received a 510(k) decision of Substantially Equivalent on December 29, 1995, 305 days after the submission was received.

What is the product code of K950856?

The FDA product code is DRO – Pacemaker, Cardiac, External Transcutaneous (Non-Invasive), a Class II (moderate risk) device regulated under 21 CFR 870.5550.