Bara-Med Acrylic Monoplace Hyperbaric Chamber
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K020974 FDA 510(k)
- FDA Product Code
- CBF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5470 FDA 510(k)
- Regulation Number
- 868.5470 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESU FDA 510(k)
The Bara-Med Acrylic Monoplace Hyperbaric Chamber is a hyperbaric chamber device designed for delivering hyperbaric oxygen therapy. It is classified as a Class II medical device under FDA regulation 868.5470 and is intended for use in the anesthesiology medical specialty.
The device is supplied as a reusable system and has received FDA 510(k) clearance under K020974. It is manufactured by Environmental Tectonics Corp. and is registered with the FDA under multiple facility identification numbers, including 3013938915 and 3016489995.
Frequently asked questions
What is the Bara-Med Acrylic Monoplace Hyperbaric Chamber used for?
It is designed for delivering hyperbaric oxygen therapy and is intended for use in the anesthesiology medical specialty, as specified in its FDA classification under regulation 868.5470.
Is the Bara-Med Acrylic Monoplace Hyperbaric Chamber reusable or single-use?
The device is supplied as a reusable system, meaning it is intended for multiple uses after proper cleaning and maintenance between treatments.
What regulatory clearance does the Bara-Med Acrylic Monoplace Hyperbaric Chamber have?
It has received FDA 510(k) clearance under submission number K020974, which was granted via a traditional review process on June 26, 2002.
Who manufactures the Bara-Med Acrylic Monoplace Hyperbaric Chamber and where is it located?
The device is manufactured by Environmental Tectonics Corp., located at 125 James Way, Southampton, PA 18966, United States.
What FDA product code and device class apply to the Bara-Med Acrylic Monoplace Hyperbaric Chamber?
It is assigned product code CBF and classified as a Class II medical device under FDA regulation 868.5470 for hyperbaric chambers.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K020974 | Class II | Active |
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Manufacturer
- Manufacturer
- Environmental Tectonics Corp.
Sources (1)
- FDA 510(k) K020974 24 fields · synced Sep 23, 2026