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510(k) Data Aggregation
K Number
K072757Device Name
DIVE AND SHALLOW AND GRAND DIVE
Manufacturer
SUMMIT TO SEA
Date Cleared
2008-02-08
(134 days)
Product Code
CBF
Regulation Number
868.5470Why did this record match?
Applicant Name (Manufacturer) :
SUMMIT TO SEA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Dive Series Hyperbaric Chambers are rugged and portable, intended to be used to treat: Acute Mountain sickness (AMS) as prescribed by or under the direction of a physician.
Device Description
Hyperbaric Dive chambers are mild hyperbaric chambers for pressures less than 5 PSI. This chamber is designed after the Gamow bag. It is composed of an airtight bag which is zipped shut with a person inside. The bag is inflated with atmospheric air with a small electric pump. The Hyperbaric Dive chambers are inflated with the Gast DDL 30. DDL40, or DDL120. The Shallow Dive, The Dive, and the Grand Dive utilize a single airtight bag with a single zipper. The bags have two relief valves set to 3.9 and 4 PSI to ensure safe operation (The Shallow Dives are set to 2.9 and 3 PSI to achieve the lower pressure). The chambers all utilize two redundant fill valves (for pressurizing the chamber from the Gast pump), one - two access ports for sampling inside air and one external pressure gauge. An optional pressure gauge can be added to the air sampling valve and positioned for viewing from the inside of the chamber. The Shallow Dive and the Dive weigh 15 pounds while the Grand Dive weighs 32 pounds. The compressor weighs 24 pounds. The bags are constructed of urethane coated nylon. The valves and ports are constructed of metal and plastic. The Shallow Dive is 7 feet long and 27 inches wide and attains 1.2 ATA (3 PSI), the Dive is 7 feet long and 27 inches wide and the Grand Dive is 9 feet long and 40 inches wide. These two chambers attain 1.3 ATA (4 PSI). All dimensions are with the devices inflated.
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