BR-50-J Disposable ECG Electrode
FDA 510(k) K921579 · Medicotest, Inc.
510(k) numberK921579
Submission
- Device name
- BR-50-J Disposable ECG Electrode
- Applicant
- Medicotest, Inc.
St. Louis, MO, US - Received
- April 2, 1992
- Decision date
- May 26, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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More from Suzuken Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K983597 | Neuroline, Disposable Monopolar Needle ElectrodesGXZ · Traditional | 01/11/1999SE |
| K970639 | Neuroline, Disposable Reference and Recording Electrodes Type No: 72000-S, 72010-KGXY · Traditional | 05/15/1997SE |
| K961643 | Medicotest ECG ElectrodesDRX · Traditional | 12/09/1996SE |
| K952176 | Disposable Neurology Electrodes Neuroline 7 30 01-KGXY · Traditional | 09/25/1995SE |
| K941568 | K-10-VS, DA-05-VS, Recording ElectrodesGXY · Traditional | 11/04/1994SE |
| K931430 | Cutaneous ElectrodeGXY · Traditional | 12/21/1993SE |
| K931426 | NF-11-E Disposable Reference/Recording ElectrodeGXY · Traditional | 12/21/1993SE |
| K926264 | Medicotest Skin FixKGX · Traditional | 04/20/1993SE |
| K914672 | QR-50-E Disposable Radiotranslucent ECG ElectrodeDRX · Traditional | 10/31/1991SE |
| K902407 | NF-50-E Disposable ECG ElectrodeDRX · Traditional | 07/31/1990SE |
Questions and answers
When was BR-50-J Disposable ECG Electrode cleared by the FDA?
BR-50-J Disposable ECG Electrode (K921579) received a 510(k) decision of Substantially Equivalent on May 26, 1992, 54 days after the submission was received.
What is the product code of K921579?
The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.