NDM Silvon ECG Electrodes

FDA 510(k) K931457 · Ndm Acquisition Corp.

Substantially Equivalent

510(k) numberK931457

Submission

Device name
NDM Silvon ECG Electrodes
Applicant
Ndm Acquisition Corp.
Dayton, OH, US
Received
March 23, 1993
Decision date
November 23, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
DRX – Electrode, Electrocardiograph
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2360
Specialty
Cardiovascular

Other 510(k)s with product code DRX

510(k)DeviceApplicantDecision
K171244PhysiotraceDRX · Traditional Nimbleheart, Inc.08/23/2017SE
K140096Hmicro Wired C-Patch Electrode, Trade Name Subject to ChangeDRX · Traditional Hmicro, Inc.07/24/2014SE
K123658Biomodule 3-M1DRX · Traditional Zephyr Technology Corporation04/24/2013SE
K101576Centerridge Diagnostic ECG Electrode, Centerridge Monitoring ECG ElectrodesDRX · Traditional Team Innovations, Inc.07/22/2010SE
K101685Ip-SetDRX · Traditional Integral Process Sas07/01/2010SE
K100129Ambu Blue Sensor Neo, Ambu Blue Sensor Neo XDRX · Abbreviated Ambu A/S06/11/2010SE
K093327Intco Tab ElectrodeDRX · Abbreviated Shanghai Intco Electrode Manufacturing Co., Ltd.05/10/2010SE
K10031512 Lead GloveDRX · Special I Needmd, Inc.04/23/2010SE
K092744Neonatal ECG Electrode, M203KENDRX · Traditional R & D Medical Products, Inc.12/10/2009SE
K092389Disposal ECG Electrodes, Model EasyrodeDRX · Traditional Suzuken Co., Ltd.10/13/2009SE

More from Suzuken Co., Ltd.

510(k)DeviceDecision
K943287Act-One Advanced Compression Technology Foot PumpJOW · Traditional 12/27/1994SE
K934601NDM Hydrogauze Wound DressingNAE · Traditional 02/15/1994SE
K914207Clearsite(R) Sterile Wound Care DressingNAE · Traditional 10/23/1991SE

Questions and answers

When was NDM Silvon ECG Electrodes cleared by the FDA?

NDM Silvon ECG Electrodes (K931457) received a 510(k) decision of Substantially Equivalent on November 23, 1993, 245 days after the submission was received.

What is the product code of K931457?

The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.