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510(k) Data Aggregation
K Number
K970482Device Name
TRANSCOM COLON HYDROTHERAPY MODEL HC-2000
Manufacturer
SRS INTL.
Date Cleared
1997-10-31
(263 days)
Product Code
KPL
Regulation Number
876.5220Why did this record match?
Applicant Name (Manufacturer) :
SRS INTL.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The indication for use of this device must be restricted to colon cleansing when medically indicated, such as before radiological or endoscopic examination.
Device Description
This device is not a kit. This device is an instrument for hydrotherapy of the colon. It introduces filtered water at a confortable temperature into the large intestine. It is an automatic system for filling and emptying water into and out of the colon and thus cleansing the colon of its contents when medically indicated such as before radiological or endoscopic examination. It is hygienic, painless and odorless. The instrument has an automatic pressure safety system; automatic disinfection; a system for collection of samples for analysis; remote and frontal panel control; a counter for the number of liters of water used; a three-way faucet; flow regulator; thermostatic mixer and an automatic temperature safety feature. It contains disposable components for use only once in the therapy
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