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FDA 510(k)

TECHNICON H*2

K-Number: K923237 · 1992-09-11

ApplicantHeraeus Kulzer, Inc.
Decision Date1992-09-11
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

TECHNICON H*2 is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Kulzer, Inc.. It received FDA 510(k) clearance on 1992-09-11 under 510(k) number K923237. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TECHNICON H*2?

TECHNICON H*2 is a medical device that received FDA 510(k) clearance on 1992-09-11. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K923237.

When did TECHNICON H*2 receive FDA 510(k) clearance?

TECHNICON H*2 received FDA 510(k) clearance on 1992-09-11, under 510(k) number K923237.

Who is the listed applicant for TECHNICON H*2?

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

What is the FDA product code for TECHNICON H*2?

The FDA product code for TECHNICON H*2 is GKZ.

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Other records listing Heraeus Kulzer, Inc. as applicant

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Related Devices (Code: GKZ)

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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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