Actimeter UB-103
by Copal, Inc.
510(k) K832724
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK832724 | Date22 Dec 1983 | 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- Withdrawn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
- DRT
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2300
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 26 Sep 2026
The Actimeter UB-103 is a cardiac monitor that includes a cardiotachometer and rate alarm, classified under device class 2. It is intended for monitoring cardiac activity and providing rate alarms.
The device is supplied as a single-use item and is not reusable. It is not specified for MRI safety. The device is regulated under FDA 510(k) clearance K832724, with a decision date of December 22, 1983.
Other devices from Copal, Inc.
Questions
AI-generated answers, 26 Sep 2026
What is the Actimeter UB-103 used for?
The Actimeter UB-103 is a cardiac monitor designed to track heart rate and alert the user if the rate exceeds a set threshold, providing a cardiotachometer and rate alarm.
Is the Actimeter UB-103 reusable?
No, the Actimeter UB-103 is supplied as a single-use item and is not intended for reuse.
What is the regulatory status of the Actimeter UB-103?
The Actimeter UB-103 is regulated under FDA 510(k) clearance, specifically K832724, which was granted on December 22, 1983.