Electrotrace, Modification
FDA 510(k) K924133 · Jason Marketing Co.
510(k) numberK924133
Submission
- Device name
- Electrotrace, Modification
- Applicant
- Jason Marketing Co.
Huntington Beach, CA, US - Received
- August 4, 1992
- Decision date
- October 30, 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 |
|---|---|---|
| K903555 | Electrotrace Disposable Ag/Agcl EKG Mon. Elec.DRX · Traditional | 11/05/1990SE |
| K896569 | Electrotrace Disposable Ag/Agcl EKG Monitor Elec.DRX · Traditional | 01/18/1990SE |
| K894679 | Electrotrace Disp. Resting EKG ElectrodesDRX · Traditional | 09/13/1989SE |
| K871626 | Electrotrace Disp Rest EKG Electrode, Cat. ET1200DRX · Traditional | 06/05/1987SE |
Questions and answers
When was Electrotrace, Modification cleared by the FDA?
Electrotrace, Modification (K924133) received a 510(k) decision of Substantially Equivalent on October 30, 1992, 87 days after the submission was received.
What is the product code of K924133?
The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.