Bowen Reuseable/Disposable Electrode
FDA 510(k) K871325 · Bowen & Company, Inc.
510(k) numberK871325
Submission
- Device name
- Bowen Reuseable/Disposable Electrode
- Applicant
- Bowen & Company, Inc.
Rockville, MD, US - Received
- April 3, 1987
- Decision date
- June 8, 1987
- 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 |
|---|---|---|
| K896898 | Bowen Electrode Skin Prepatory CleanserLKB · Traditional | 04/04/1990SE |
| K896538 | Disposable 45 Degree ShaverHRX · Traditional | 12/06/1989SE |
| K873766 | Sternal Power AwlKIJ · Traditional | 11/14/1988SE |
| K872098 | Cremeen Alveolar Bone CaliperEIL · Traditional | 07/31/1987SE |
| K870882 | 45 Degree ShaverHTZ · Traditional | 03/23/1987SE |
| K870881 | Loose Body GraspersHTD · Traditional | 03/23/1987SE |
| K863150 | Bowen CannulaGEA · Traditional | 09/05/1986SE |
| K863149 | Bowen ProbeHXB · Traditional | 09/05/1986SE |
| K863148 | Bowen Knot PasserHXI · Traditional | 09/05/1986SE |
| K863147 | Glenoid DrillHTW · Traditional | 09/05/1986SE |
Questions and answers
When was Bowen Reuseable/Disposable Electrode cleared by the FDA?
Bowen Reuseable/Disposable Electrode (K871325) received a 510(k) decision of Substantially Equivalent on June 8, 1987, 66 days after the submission was received.
What is the product code of K871325?
The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.