Model 3000 Hyperbaric Chamber
by Custom Craft Products, Inc. 510(k)
Active
510(k) K841608
Overview
The Model 3000 Hyperbaric Chamber is a medical device classified as a hyperbaric chamber, designed for the administration of hyperbaric oxygen therapy (HBOT). It operates by exposing patients to elevated atmospheric pressures, typically in combination with 100% oxygen, to enhance oxygen delivery to tissues and promote healing in conditions such as decompression sickness, carbon monoxide poisoning, or wound healing complications. This device adheres to regulatory standards for hyperbaric chambers and is intended for use in clinical settings where controlled pressure environments are required for therapeutic purposes.
The Model 3000 Hyperbaric Chamber is a reusable device supplied as a complete system for use in medical facilities, including hospitals and specialized hyperbaric treatment centers. It is regulated under FDA 510(k) clearance (K841608) and falls under the classification of Class II medical devices. The chamber is designed for repeated use in controlled environments, with specifications aligned to meet regulatory requirements for hyperbaric oxygen therapy. No specific sterility or MRI safety information is provided in the data, but it is intended for use in clinical settings where proper maintenance and operational protocols are followed.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK841608 | Date2 May 1984 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 5 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- CBF
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5470
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Questions
What is the Model 3000 Hyperbaric Chamber used for?
The Model 3000 Hyperbaric Chamber is designed for hyperbaric oxygen therapy (HBOT), a treatment that exposes patients to elevated atmospheric pressures while breathing 100% oxygen. This enhances oxygen delivery to tissues, aiding in healing conditions such as decompression sickness, carbon monoxide poisoning, and complications from wound healing. The device is intended for use in controlled clinical environments like hospitals or specialized hyperbaric treatment centers.
Is the Model 3000 Hyperbaric Chamber reusable or single-use?
The Model 3000 Hyperbaric Chamber is a reusable medical device. It is supplied as a complete system for repeated use in clinical settings, provided proper maintenance and operational protocols are followed. This design ensures durability and compliance with regulatory standards for hyperbaric oxygen therapy.
What regulatory approval does the Model 3000 Hyperbaric Chamber hold?
The Model 3000 Hyperbaric Chamber holds FDA 510(k) clearance under the reference number K841608. This clearance indicates that the device is classified as substantially equivalent to a legally marketed predicate device and falls under the classification of Class II medical devices. The device adheres to regulatory standards for hyperbaric chambers.
How is the Model 3000 Hyperbaric Chamber supplied?
The Model 3000 Hyperbaric Chamber is supplied as a complete system for use in medical facilities. It is intended for installation in controlled environments such as hospitals or specialized hyperbaric treatment centers. The system includes all necessary components for administering hyperbaric oxygen therapy, ensuring readiness for clinical use.
Are there any specific sterility or MRI safety requirements for the Model 3000 Hyperbaric Chamber?
The provided data does not specify sterility requirements or MRI safety information for the Model 3000 Hyperbaric Chamber. However, as with all medical devices used in clinical settings, proper maintenance and adherence to operational protocols are essential. Users should follow manufacturer guidelines and local regulatory standards to ensure safe and effective use.