Diagnostic ECG Disposable Electrode
FDA 510(k) K851522 · Sentry Medical Products, Inc.
510(k) numberK851522
Submission
- Device name
- Diagnostic ECG Disposable Electrode
- Applicant
- Sentry Medical Products, Inc.
Santa Ana, CA, US - Received
- April 15, 1985
- Decision date
- October 24, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DRX – Electrode, Electrocardiograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2360
- Specialty
- Cardiovascular
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| 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 |
|---|---|---|
| K962122 | Sentry Radiotranslucent ECG ElectrodesDRX · Traditional | 07/24/1996SE |
| K955636 | Sentry Disposable Dispersive ElectrodeJOS · Traditional | 03/27/1996SE |
| K942827 | Sentry Insertion TrayFOS · Traditional | 11/02/1994SE |
| K934000 | Sentry Aqueous Gel ECG ElectrodesDRX · Traditional | 08/30/1994SE |
| K935098 | Baby BoardBTX · Traditional | 02/15/1994SE |
| K933603 | LeadwireDSA · Traditional | 01/18/1994SE |
| K932704 | Patient CableDSA · Traditional | 12/27/1993SE |
| K881670 | Accutemp PlusFMT · Traditional | 11/22/1988SE |
| K881343 | Duraderm ButterflyGXY · Traditional | 05/04/1988SE |
| K853552 | Sentry Flexible TENSGXY · Traditional | 09/26/1985SE |
Questions and answers
When was Diagnostic ECG Disposable Electrode cleared by the FDA?
Diagnostic ECG Disposable Electrode (K851522) received a 510(k) decision of Substantially Equivalent on October 24, 1985, 192 days after the submission was received.
What is the product code of K851522?
The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.