Companion 318 Nasal CPAP System
by Puritan Bennett Corp. 510(k)
Active
510(k) K903764
Overview
The Companion 318 Nasal CPAP System is an attachment for breathing that provides positive end expiratory pressure. It is classified as a Class II medical device under product code BYE and regulation number 868.5965.
The device received FDA 510(k) clearance K903764 on September 10, 1990, and was found substantially equivalent. It was submitted by Puritan Bennett Corp. and is intended for use in anesthesiology settings.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK903764 | Date10 Sep 1990 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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
- BYE
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5965
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Puritan Bennett Corp.
Questions
What is the Companion 318 Nasal CPAP System intended for?
The Companion 318 Nasal CPAP System is intended for use in anesthesiology settings to provide positive end expiratory pressure as an attachment for breathing, based on its FDA 510(k) clearance and product classification.
How was the Companion 318 Nasal CPAP System cleared for market?
The device received FDA 510(k) clearance K903764 on September 10, 1990, and was found substantially equivalent to a predicate device, allowing it to be marketed as a Class II medical device under product code BYE.
What regulatory classification does the Companion 318 Nasal CPAP System have?
The Companion 318 Nasal CPAP System is classified as a Class II medical device under FDA product code BYE and regulation number 868.5965, as specified in its 510(k) submission and clearance documentation.