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FDA 510(k)

MODEL 1001

K-Number: K844718 · 1985-01-28

ApplicantA0kfusion Systems, Inc.
Decision Date1985-01-28
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MODEL 1001 is the device name listed in this FDA 510(k) record. The listed applicant is A0kfusion Systems, Inc.. It received FDA 510(k) clearance on 1985-01-28 under 510(k) number K844718. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 1001?

MODEL 1001 is a medical device that received FDA 510(k) clearance on 1985-01-28. The listed applicant is A0kfusion Systems, Inc.. The 510(k) number is K844718.

When did MODEL 1001 receive FDA 510(k) clearance?

MODEL 1001 received FDA 510(k) clearance on 1985-01-28, under 510(k) number K844718.

Who is the listed applicant for MODEL 1001?

The FDA 510(k) record lists A0kfusion Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL 1001?

The FDA product code for MODEL 1001 is FRN.

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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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