FDA 510(k)

COMBISON 100-MODEL 100 & 110

K-Number: K800091 · 1980-02-11

Decision Date1980-02-11

Product CodeIYO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

COMBISON 100-MODEL 100 & 110 is the device name listed in this FDA 510(k) record. The listed applicant is Kt Medical, Inc.. It received FDA 510(k) clearance on 1980-02-11 under 510(k) number K800091. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMBISON 100-MODEL 100 & 110?

COMBISON 100-MODEL 100 & 110 is a medical device that received FDA 510(k) clearance on 1980-02-11. The listed applicant is Kt Medical, Inc.. The 510(k) number is K800091.

When did COMBISON 100-MODEL 100 & 110 receive FDA 510(k) clearance?

COMBISON 100-MODEL 100 & 110 received FDA 510(k) clearance on 1980-02-11, under 510(k) number K800091.

Who is the listed applicant for COMBISON 100-MODEL 100 & 110?

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

What is the FDA product code for COMBISON 100-MODEL 100 & 110?

The FDA product code for COMBISON 100-MODEL 100 & 110 is IYO.

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Other records listing Kt Medical, Inc. as applicant

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Official Source

View on FDA Database →

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