Liberator/Stroller
by Burditt & Calkins-Siemens-Elema
510(k) K760787
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK760787 | Date22 Oct 1976 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- BYJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5655
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 24 Sep 2026
The LIBERATOR/STROLLER is a portable unit for liquid oxygen classified under medical specialty anesthesiology. It is designed to provide a portable oxygen supply system for medical use.
The device is supplied as a Class 2 medical device with FDA 510(k) clearance K760787, received on October 6, 1976, and decided as substantially equivalent on October 22, 1976. It is regulated under number 868.5655 and was reviewed by the Anesthesiology advisory committee.
Other devices from Burditt & Calkins-Siemens-Elema
Questions
AI-generated answers, 24 Sep 2026
What is the LIBERATOR/STROLLER used for?
The LIBERATOR/STROLLER is a portable unit designed to provide a liquid oxygen supply system for medical use, specifically classified under the medical specialty of anesthesiology.
How is the LIBERATOR/STROLLER supplied and what is its regulatory status?
The device is supplied as a Class 2 medical device with FDA 510(k) clearance K760787, received on October 6, 1976, and decided as substantially equivalent on October 22, 1976. It is regulated under number 868.5655.
What are the specifications and model details of the LIBERATOR/STROLLER?
The LIBERATOR/STROLLER is a portable liquid oxygen unit with product code BYJ. It was reviewed by the Anesthesiology advisory committee and manufactured by Burditt & Calkins-Siemens-Elema. The device is designed for portability in medical settings requiring oxygen supply.
Is the LIBERATOR/STROLLER single-use or reusable?
The device information does not specify whether the LIBERATOR/STROLLER is intended for single-use or multiple uses. As a portable oxygen supply system, it may be designed for repeated use depending on the specific model and configuration.