CARDIO-3 Channel Electrocardiograph
510(k) K850454
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK850454 | Date1 Mar 1985 | 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- Withdrawn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
- DPS
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2340
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 27 Sep 2026
The Cardio-3 Channel Electrocardiograph is a medical device designed to record and monitor the electrical activity of the heart. It functions as a diagnostic tool to capture three channels of electrocardiographic data for clinical assessment.
This device is identified by FDA 510(k) clearance number K850454. It is manufactured by Zimmer Elektromedizin GmbH and was subject to a traditional premarket notification process.
Other devices from Zimmer Elektromedizin GmbH
Questions
AI-generated answers, 27 Sep 2026
What is the primary function of the Cardio-3 Channel Electrocardiograph?
This device is designed to serve as a diagnostic tool for clinical assessment by recording and monitoring the electrical activity of the heart across three distinct channels.
Who is the manufacturer of this electrocardiograph?
The device is manufactured by Zimmer Elektromedizin GmbH, located in Neu-Ulm, Germany.
What is the regulatory status of this device?
The Cardio-3 Channel Electrocardiograph has received FDA 510(k) clearance under the number K850454, following a traditional premarket notification process.