RespiEvents Software
by Non-Invasive Monitoring Systems, Inc.
510(k) K012020
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK012020 | Date21 Aug 2001 | 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- Withdrawn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
- Respievents Software Is Event Data Processing Sofware for a Pc
- 510(k) Number
- FDA Product Code
- DQK
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1425
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 27 Sep 2026
RespiEvents Software is event data processing software for a PC. It functions as a programmable diagnostic computer designed to process event data.
This software is supplied by Non-Invasive Monitoring Systems, Inc. and has received FDA 510(k) clearance. It is categorized under product code DQK.
Other devices from Non-Invasive Monitoring Systems, Inc.
Questions
AI-generated answers, 27 Sep 2026
What is the primary function of RespiEvents Software?
RespiEvents Software acts as a programmable diagnostic computer program. It is specifically designed to process event data when installed on a personal computer.
What is the regulatory status of this software?
RespiEvents Software has received FDA 510(k) clearance, identified by K-number K012020. This indicates the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.
How is this software categorized for regulatory purposes?
The software is categorized under product code DQK and falls under the oversight of the Cardiovascular advisory committee, which reflects the clinical area associated with its data processing capabilities.