Event Master Recorder
by Instruments For Cardiac Research
510(k) K812920
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK812920 | Date2 Dec 1981 | 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- Withdrawn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
- Full name
- Event Master
- 510(k) Number
- FDA Product Code
- DSH
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2800
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Event Master is a Recorder, Magnetic Tape, Medical designed for capturing and recording cardiac electrical activity. It functions as a portable diagnostic tool to monitor arrhythmias and other cardiac events over extended periods, providing continuous electrocardiographic (ECG) data for clinical evaluation. Its magnetic tape storage enables long-duration recordings, distinguishing it from shorter-duration Holter monitors.
This device is intended for use in clinical settings, such as cardiology offices or hospitals, and is supplied as a reusable medical instrument. It operates under FDA 510(k) clearance (K812920) and falls under Class II (DSH) regulatory classification. No specific sterility or MRI safety information is provided in the data, and its design does not indicate single-use constraints. Storage and handling follow standard medical device protocols for reusable diagnostic equipment.