Healthdyne Event Recorder System
by Healthdyne, Inc. 510(k)
Active
510(k) K860254
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK860254 | Date30 Jan 1986 | 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- Withdrawn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
- Full name
- Healthdyne's Event Recorder System
- 510(k) Number
- FDA Product Code
- BZQ
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.2375
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
The Healthdyne Event Recorder System is a breathing frequency monitor. It is designed to track and record respiratory events as a medical device.
This system is regulated under the anesthesiology specialty and is classified as a class 2 device. It received FDA 510(k) clearance under the reference number K860254.
Other devices from Healthdyne, Inc.
Questions
AI-generated answers, 22 Sep 2026
What is the primary function of the Healthdyne Event Recorder System?
This device is designed to function as a breathing frequency monitor. Its primary purpose is to track and record respiratory events in a clinical setting.
How is this device classified for regulatory purposes?
The Healthdyne Event Recorder System is classified as a class 2 medical device under the anesthesiology specialty, regulated under the number 868.2375.
What is the regulatory history of this device?
The system received FDA 510(k) clearance under the reference number K860254. This clearance was granted following a traditional submission process.