Disposable ECG Monitoring Electrodes, Models 4060, 4610
FDA 510(k) K990112 · Maersk Medical A/S
510(k) numberK990112
Submission
- Device name
- Disposable ECG Monitoring Electrodes, Models 4060, 4610
- Applicant
- Maersk Medical A/S
Fort Worth, TX, US - Received
- January 13, 1999
- Decision date
- December 6, 1999
- 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
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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 |
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More from Suzuken Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K011071 | Paradigm Quick-Set Infusion SetFPA · Traditional | 06/07/2001SE |
| K002138 | Paradigm Silhouette, Models MMT-377, 378, 379, 380FPA · Traditional | 08/29/2000SE |
| K990115 | Disposable ECG Monitoring Electrodes, Models, 4420, 4440DRX · Traditional | 12/06/1999SE |
| K990113 | Disposable ECG Monitoring Electrodes, Models 4500,4530, 4533, 4539, 4540, and 4560DRX · Traditional | 12/06/1999SE |
| K990111 | Disposable ECG Monitoring Electrodes, Models 4520, 4535, 4570DRX · Traditional | 12/06/1999SE |
| K990110 | Disposable ECG Monitoring Electrodes, Model 4110, 4140DRX · Traditional | 12/06/1999SE |
| K991759 | Maersk Medical Contour Infusion SetFPA · Traditional | 06/25/1999SE |
| K973364 | 4L Drainage Bag, 4L Bag for Peritoneal Dialysis, 4L Urinary Drainage BagKNX · Traditional | 03/17/1998SE |
Questions and answers
When was Disposable ECG Monitoring Electrodes, Models 4060, 4610 cleared by the FDA?
Disposable ECG Monitoring Electrodes, Models 4060, 4610 (K990112) received a 510(k) decision of Substantially Equivalent on December 6, 1999, 327 days after the submission was received.
What is the product code of K990112?
The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.