Nasal Interface Model 7910
by Healthdyne Technologies, Inc. 510(k)
Active
510(k) K974453
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK974453 | Date4 Aug 1998 | 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- Withdrawn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
- BZD
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5905
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
The Nasal Interface Model 7910 is a ventilator, non-continuous, or respirator device. It is classified as a Class 2 device under product code BZD.
The Nasal Interface Model 7910 is intended for use with nasal CPAP and bilevel devices for the treatment of adult patients with Obstructive Sleep Apnea. It was cleared by the FDA through the 510k pathway on August 4, 1998, with the clearance number K974453.
Other devices from Healthdyne Technologies, Inc.
Questions
AI-generated answers, 22 Sep 2026
What is the Nasal Interface Model 7910 used for?
The Nasal Interface Model 7910 is used for the treatment of adult patients with Obstructive Sleep Apnea, in conjunction with nasal CPAP and bilevel devices.
Is the Nasal Interface Model 7910 a single-use or reusable device?
The provided data does not specify whether the Nasal Interface Model 7910 is single-use or reusable, but it is classified as a Class 2 device.
What is the regulatory classification of the Nasal Interface Model 7910?
The Nasal Interface Model 7910 is classified under product code BZD and has been cleared by the FDA through the 510k pathway.
What type of ventilator is the Nasal Interface Model 7910?
The Nasal Interface Model 7910 is a non-continuous ventilator or respirator device.