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FDA 510(k)

MODEL TT25RF

K-Number: K844178 · 1985-10-18

ApplicantInframed, Inc.
Decision Date1985-10-18
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODEL TT25RF is the device name listed in this FDA 510(k) record. The listed applicant is Inframed, Inc.. It received FDA 510(k) clearance on 1985-10-18 under 510(k) number K844178. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL TT25RF?

MODEL TT25RF is a medical device that received FDA 510(k) clearance on 1985-10-18. The listed applicant is Inframed, Inc.. The 510(k) number is K844178.

When did MODEL TT25RF receive FDA 510(k) clearance?

MODEL TT25RF received FDA 510(k) clearance on 1985-10-18, under 510(k) number K844178.

Who is the listed applicant for MODEL TT25RF?

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

What is the FDA product code for MODEL TT25RF?

The FDA product code for MODEL TT25RF is GEX. This falls under the Gastroenterology category.

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Other records listing Inframed, Inc. as applicant

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Official Source

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