BM-103 Battery Module
by Datex Division Instrumentarium Corp. 510(k)
Active
510(k) K883877
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK883877 | Date28 Oct 1988 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DQA
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2700
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
The BM-103 Battery Module is a power component designed to provide backup and uninterruptible power supply functionality. It serves as a supporting module for medical instrumentation systems.
This device is supplied by Datex Division Instrumentarium Corp. and has received FDA 510(k) clearance. It is categorized under product code DQA and is associated with the anesthesiology specialty.
Other devices from Datex Division Instrumentarium Corp.
Questions
AI-generated answers, 22 Sep 2026
What is the primary function of the BM-103 Battery Module?
The BM-103 is designed to serve as a power component for medical instrumentation systems. Its primary purpose is to provide backup and uninterruptible power supply functionality to ensure the continued operation of connected medical devices.
Who is the manufacturer of this battery module?
This device is manufactured by the Datex Division Instrumentarium Corp., which is based in Helsinki, Finland.
What is the regulatory status of the BM-103 Battery Module?
The BM-103 Battery Module has received FDA 510(k) clearance under the submission number K883877. It is categorized under product code DQA and is associated with the anesthesiology specialty.