Tdk Ecg Electrode MEL-10
by Tdk Corp.
510(k) K870834
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK870834 | Date23 Mar 1987 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DRX
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2360
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 21 Sep 2026
The Tdk Ecg Electrode Mel-10 is an electrocardiograph electrode designed for use in cardiovascular diagnostic procedures. It functions as a sensor to detect and record the electrical activity of the heart.
This device is identified by FDA 510(k) number K870834 and is classified as a class 2 medical device. It is manufactured by Tdk Corp. and has received FDA 510(k) clearance.
Other devices from Tdk Corp.
Questions
AI-generated answers, 21 Sep 2026
What is the primary function of the TDK ECG Electrode MEL-10?
The MEL-10 is designed for use in cardiovascular diagnostic procedures. It acts as a sensor that detects and records the electrical activity of the heart to assist clinicians in monitoring cardiac function.
What is the regulatory status of this device?
The TDK ECG Electrode MEL-10 is a class 2 medical device that has received FDA 510(k) clearance under the number K870834. The device was determined to be substantially equivalent to existing products during its review process.
Who is the manufacturer of the MEL-10 electrode?
This device is manufactured by TDK Corp., located in Ichikawa-Shi, Chiba, Japan. The product was submitted for regulatory review in March 1987.