EKG Vest
FDA 510(k) K932903 · Cardiotronics, Inc.
510(k) numberK932903
Submission
- Device name
- EKG Vest
- Applicant
- Cardiotronics, Inc.
Washington, DC, US - Received
- June 16, 1993
- Decision date
- February 24, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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) | Device | Applicant | Decision |
|---|---|---|---|
| K171244 | PhysiotraceDRX · Traditional | Nimbleheart, Inc. | 08/23/2017SE |
| K140096 | Hmicro Wired C-Patch Electrode, Trade Name Subject to ChangeDRX · Traditional | Hmicro, Inc. | 07/24/2014SE |
| K123658 | Biomodule 3-M1DRX · Traditional | Zephyr Technology Corporation | 04/24/2013SE |
| K101576 | Centerridge Diagnostic ECG Electrode, Centerridge Monitoring ECG ElectrodesDRX · Traditional | Team Innovations, Inc. | 07/22/2010SE |
| K101685 | Ip-SetDRX · Traditional | Integral Process Sas | 07/01/2010SE |
| K100129 | Ambu Blue Sensor Neo, Ambu Blue Sensor Neo XDRX · Abbreviated | Ambu A/S | 06/11/2010SE |
| K093327 | Intco Tab ElectrodeDRX · Abbreviated | Shanghai Intco Electrode Manufacturing Co., Ltd. | 05/10/2010SE |
| K100315 | 12 Lead GloveDRX · Special | I Needmd, Inc. | 04/23/2010SE |
| K092744 | Neonatal ECG Electrode, M203KENDRX · Traditional | R & D Medical Products, Inc. | 12/10/2009SE |
| K092389 | Disposal ECG Electrodes, Model EasyrodeDRX · Traditional | Suzuken Co., Ltd. | 10/13/2009SE |
More from Suzuken Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K922064 | Model #510 Stealth-Plate Dispersive ElectrodeGXD · Traditional | 12/01/1992SE |
| K923297 | Model #340 Stealth-Trode+LsLDD · Traditional | 09/18/1992SE |
| K922227 | Model #225-ST Shock-Trode Adult Defib Pads SterileLDD · Traditional | 06/11/1992SE |
| K922173 | Model # 830 ST Adult Stimulation Pads (Sterile)LDD · Traditional | 06/11/1992SE |
| K922172 | Model # 230 ST Stealth-Trode Defib Pads (Sterile)LDD · Traditional | 06/11/1992SE |
| K921606 | Model #125 Child Stimulation PadsLDD · Traditional | 05/26/1992SE |
| K920086 | Shock-Patch Adult Defibrillation PadsLDD · Traditional | 02/03/1992SE |
| K914725 | Coordinator, Cable InputDPS · Traditional | 11/05/1991SE |
| K912621 | Model #911 Stealth Multi PadsLDD · Traditional | 10/16/1991SE |
| K911456 | Model #110 Stealth-Trode Child Defib PadsLDD · Traditional | 10/16/1991SE |
Questions and answers
When was EKG Vest cleared by the FDA?
EKG Vest (K932903) received a 510(k) decision of Substantially Equivalent on February 24, 1995, 618 days after the submission was received.
What is the product code of K932903?
The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.