Argus, Model LCM
by Schiller AG
510(k) K053207
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK053207 | Date19 May 2006 | StatusActive |
Official records
- FDA 510(k) database K053207
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MHX
- Device class
- Class II
- Regulation
- 21 CFR Part 870.1025
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 6 Oct 2026
The Argus, Model LCM is a physiological patient monitor with arrhythmia detection or alarms, classified as a Class II medical device. It is substantially equivalent to a predicate device and received traditional 510(k) clearance from the FDA. The device is intended for cardiovascular monitoring applications.
It is manufactured by Schiller AG and supplied as a reusable patient monitor. The device requires connection to power and patient sensors for operation, and is used in clinical settings for continuous physiological monitoring. Storage and handling should follow the manufacturer's instructions provided in the operating and service manuals.
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