Sechrist Monoplace Hyperbaric Oxygen Chamber
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K140559 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
- SESE Substantially Equivalent FDA 510(k)
This device is a monoplace hyperbaric oxygen chamber, designed for delivering hyperbaric oxygen therapy to a single patient at a time. It is classified as a Class II medical device under FDA regulation 868.5470 and is intended for use in the field of anesthesiology.
The chamber was cleared via the FDA 510(k) process under K140559, with a special clearance type and substantial equivalence determination. It is manufactured by Sechrist Industries Inc. in Anaheim, California, and is supplied as a reusable system for clinical use in hyperbaric oxygen therapy settings.
Frequently asked questions
What is the SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER used for?
It is designed for delivering hyperbaric oxygen therapy to a single patient at a time, intended for use in the field of anesthesiology as a Class II medical device under FDA regulation 868.5470.
Is the SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER reusable or single-use?
It is supplied as a reusable system for clinical use in hyperbaric oxygen therapy settings, meaning it is designed for multiple patient uses after proper cleaning and maintenance between treatments.
How was the SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER cleared for market?
It was cleared via the FDA 510(k) process under submission K140559, with a special clearance type and a determination of substantial equivalence to a legally marketed predicate device.
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. Sources consulted: Sechrist 3600HR Monoplace Chamber | HyperbaricStore, Sechrist Industries | respiratory, HBO - Sechristusa
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K140559 | Class II | Active |
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Manufacturer
- Manufacturer
- Sechrist Industries Inc
- FDA Applicant
- Sechrist Industries, Inc.
Sources (1)
- FDA 510(k) K140559 24 fields · synced Sep 26, 2026