Econo Mate
by Mountain Medical Equipment, Inc. 510(k)
Active
510(k) K843715
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK843715 | Date10 Oct 1984 | 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- Withdrawn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
- CAW
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5440
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 25 Sep 2026
The Econo Mate is a portable oxygen generator. It is classified as a medical device intended for use in anesthesiology applications.
This device is authorized under FDA 510(k) clearance K843715. It is manufactured by Mountain Medical Equipment, Inc. and is categorized as a class 2 device.
Other devices from Mountain Medical Equipment, Inc.
Questions
AI-generated answers, 25 Sep 2026
What is the intended use of the Econo Mate?
The Econo Mate is a portable oxygen generator specifically intended for use in anesthesiology applications.
What is the regulatory status of this device?
The Econo Mate is authorized under FDA 510(k) clearance number K843715. It is classified as a class 2 medical device.
Who is the manufacturer of the Econo Mate?
The device is manufactured by Mountain Medical Equipment, Inc., located in Littleton, Colorado.