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FDA 510(k)

MODEL P-81 CRITIKON PRINTER

K-Number: K915468 · 1992-09-22

ApplicantCritkon, Inc.
Decision Date1992-09-22
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL P-81 CRITIKON PRINTER is the device name listed in this FDA 510(k) record. The listed applicant is Critkon, Inc.. It received FDA 510(k) clearance on 1992-09-22 under 510(k) number K915468. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL P-81 CRITIKON PRINTER?

MODEL P-81 CRITIKON PRINTER is a medical device that received FDA 510(k) clearance on 1992-09-22. The listed applicant is Critkon, Inc.. The 510(k) number is K915468.

When did MODEL P-81 CRITIKON PRINTER receive FDA 510(k) clearance?

MODEL P-81 CRITIKON PRINTER received FDA 510(k) clearance on 1992-09-22, under 510(k) number K915468.

Who is the listed applicant for MODEL P-81 CRITIKON PRINTER?

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

What is the FDA product code for MODEL P-81 CRITIKON PRINTER?

The FDA product code for MODEL P-81 CRITIKON PRINTER is DXN.

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Related Devices (Code: DXN)

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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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