ZOLL PD 2200 Pacing-Defibrillation Electrodes
by Zmi Corp. 510(k)
Active
510(k) K895032
Overview
The device is a DC-defibrillator, low-energy, including paddles, used for pacing and defibrillation. It is designed to deliver electrical therapy to the heart for the treatment of life-threatening arrhythmias.
The electrodes are supplied as a reusable device and are intended for use in clinical settings. They are authorized under FDA 510(k) clearance (K895032) and are classified as Class II medical devices under regulation number 870.5300. No information regarding sterility, single-use status, MRI safety, sizes, or storage conditions is provided in the data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK895032 | Date12 Oct 1989 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- LDD
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.5300
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Zmi Corp.
Questions
What is the ZOLL PD 2200 Pacing-Defibrillation Electrode used for?
The ZOLL PD 2200 is a DC-defibrillator, low-energy device including paddles, designed to deliver electrical therapy to the heart for the treatment of life-threatening arrhythmias through pacing and defibrillation functions.
Is the ZOLL PD 2200 electrode reusable or single-use?
The electrodes are supplied as a reusable device, as explicitly stated in the description, and are intended for repeated use in clinical settings after appropriate cleaning and maintenance between uses.
How is the ZOLL PD 2200 electrode supplied and for what setting is it intended?
The device is supplied as a reusable electrode system and is intended for use in clinical settings, where it delivers electrical therapy for pacing and defibrillation to manage life-threatening cardiac arrhythmias.
What regulatory authorization does the ZOLL PD 2200 electrode have?
The ZOLL PD 2200 Pacing-Defibrillation Electrode is authorized under FDA 510(k) clearance with K-number K895032 and is classified as a Class II medical device under regulation number 870.5300.
What clinical specialty is the ZOLL PD 2200 electrode associated with?
The device is associated with the cardiovascular medical specialty, as indicated by the product code LDD, advisory committee classification CV, and medical specialty description Cardiovascular in the regulatory data.