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Liberator/Stroller

by Burditt & Calkins-Siemens-Elema

510(k) K760787

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK760787 Date22 Oct 1976ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

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Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • 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.