F40 K Karaya Gum Disp. Pe-Foam ECG Electrode, 40MM
FDA 510(k) K884981 · S & W Medico Teknik
510(k) numberK884981
Submission
- Device name
- F40 K Karaya Gum Disp. Pe-Foam ECG Electrode, 40MM
- Applicant
- S & W Medico Teknik
Denmark, DK - Received
- November 29, 1988
- Decision date
- March 10, 1989
- 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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Questions and answers
When was F40 K Karaya Gum Disp. Pe-Foam ECG Electrode, 40MM cleared by the FDA?
F40 K Karaya Gum Disp. Pe-Foam ECG Electrode, 40MM (K884981) received a 510(k) decision of Substantially Equivalent on March 10, 1989, 101 days after the submission was received.
What is the product code of K884981?
The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.