Electrotrace Disposable Ag/Agcl EKG Monitor Elec.
FDA 510(k) K896569 · Jason Marketing Co.
510(k) numberK896569
Submission
- Device name
- Electrotrace Disposable Ag/Agcl EKG Monitor Elec.
- Applicant
- Jason Marketing Co.
Huntington Beach, CA, US - Received
- November 20, 1989
- Decision date
- January 18, 1990
- 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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More from Suzuken Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K924133 | Electrotrace, ModificationDRX · Traditional | 10/30/1992SE |
| K903555 | Electrotrace Disposable Ag/Agcl EKG Mon. Elec.DRX · Traditional | 11/05/1990SE |
| 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 Disposable Ag/Agcl EKG Monitor Elec. cleared by the FDA?
Electrotrace Disposable Ag/Agcl EKG Monitor Elec. (K896569) received a 510(k) decision of Substantially Equivalent on January 18, 1990, 59 days after the submission was received.
What is the product code of K896569?
The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.