Epcor
by Siemens Medical Solutions USA, Inc.
510(k) K930786
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK930786 | Date26 Sep 1994 | StatusActive |
Official records
- FDA 510(k) database K930786
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DRW
- Device class
- Class II
- Regulation
- 21 CFR Part 870.2350
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 23 Sep 2026
The Epcor is an electrocardiograph lead switching adaptor. It functions as a device component designed to facilitate the switching of leads within an electrocardiograph system.
This device is regulated under FDA 510K clearance as a class 2 medical device. It is categorized under regulation number 870.2350 for use within the cardiovascular medical specialty.