Disposable ECG Monitoring Electrodes, Models 4500,4530, 4533, 4539, 4540, and 4560
FDA 510(k) K990113 · Maersk Medical A/S
510(k) numberK990113
Submission
- Device name
- Disposable ECG Monitoring Electrodes, Models 4500,4530, 4533, 4539, 4540, and 4560
- 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 |
| K990112 | Disposable ECG Monitoring Electrodes, Models 4060, 4610DRX · 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 4500,4530, 4533, 4539, 4540, and 4560 cleared by the FDA?
Disposable ECG Monitoring Electrodes, Models 4500,4530, 4533, 4539, 4540, and 4560 (K990113) 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 K990113?
The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.