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FDA 510(k)

TRANSCOM COLON HYDROTHERAPY MODEL HC-2000

K-Number: K970482 · 1997-10-31

ApplicantSrs Intl.
Decision Date1997-10-31
Product CodeKPL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TRANSCOM COLON HYDROTHERAPY MODEL HC-2000 is the device name listed in this FDA 510(k) record. The listed applicant is Srs Intl.. It received FDA 510(k) clearance on 1997-10-31 under 510(k) number K970482. The device is classified under product code KPL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRANSCOM COLON HYDROTHERAPY MODEL HC-2000?

TRANSCOM COLON HYDROTHERAPY MODEL HC-2000 is a medical device that received FDA 510(k) clearance on 1997-10-31. The listed applicant is Srs Intl.. The 510(k) number is K970482.

When did TRANSCOM COLON HYDROTHERAPY MODEL HC-2000 receive FDA 510(k) clearance?

TRANSCOM COLON HYDROTHERAPY MODEL HC-2000 received FDA 510(k) clearance on 1997-10-31, under 510(k) number K970482.

Who is the listed applicant for TRANSCOM COLON HYDROTHERAPY MODEL HC-2000?

The FDA 510(k) record lists Srs Intl. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRANSCOM COLON HYDROTHERAPY MODEL HC-2000?

The FDA product code for TRANSCOM COLON HYDROTHERAPY MODEL HC-2000 is KPL.

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Related Devices (Code: KPL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K201861Bio Fluff SystemGnali Bocia S.R.L.K180800Colonic Plus Regular, Small, and Straight Shape HydrokitColonic PlusK152834Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10Colonplus Equipments & Speculums, S.L.K094022THE WATER LILYClearwater Products, LLCK071057COLONIC & ENEMA NOZZLETiller Mind Body, Inc.K051344COLONIC AND ENEMA NOZZLEUltimate Concepts, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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