Em III Disposable Electrode
FDA 510(k) K863845 · Electromed Intl., Ltd.
510(k) numberK863845
Submission
- Device name
- Em III Disposable Electrode
- Applicant
- Electromed Intl., Ltd.
Waltham, MA, US - Received
- October 1, 1986
- Decision date
- November 20, 1986
- 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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| K971176 | View Archiving StationIZI · Traditional | 09/03/1997SE |
| K950694 | Compact-XIZO · Traditional | 03/31/1995SE |
| K880050 | Edec 60RIZO · Traditional | 02/29/1988SE |
| K875341 | Edec 60 R/FIZO · Traditional | 02/01/1988SE |
| K875342 | Edec 90CIZO · Traditional | 01/29/1988SE |
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Questions and answers
When was Em III Disposable Electrode cleared by the FDA?
Em III Disposable Electrode (K863845) received a 510(k) decision of Substantially Equivalent on November 20, 1986, 50 days after the submission was received.
What is the product code of K863845?
The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.