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FDA 510(k)

SUPERIX 120

K-Number: K811197 · 1981-06-09

ApplicantTecnomed, Inc.
Decision Date1981-06-09
Product CodeIZF
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SUPERIX 120 is the device name listed in this FDA 510(k) record. The listed applicant is Tecnomed, Inc.. It received FDA 510(k) clearance on 1981-06-09 under 510(k) number K811197. The device is classified under product code IZF. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUPERIX 120?

SUPERIX 120 is a medical device that received FDA 510(k) clearance on 1981-06-09. The listed applicant is Tecnomed, Inc.. The 510(k) number is K811197.

When did SUPERIX 120 receive FDA 510(k) clearance?

SUPERIX 120 received FDA 510(k) clearance on 1981-06-09, under 510(k) number K811197.

Who is the listed applicant for SUPERIX 120?

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

What is the FDA product code for SUPERIX 120?

The FDA product code for SUPERIX 120 is IZF.

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Related Devices (Code: IZF)

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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.

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