FDA 510(k)

THE MAYFIELD / ACCISS SYSTEM WITH WINDOWS NT FOR CRANIAL SURGERY, THE MAYFIELD / OPTICAL ACCISS SYSTEM WITH WINDOWS NT F

K-Number: K992843 · 1999-11-02

ApplicantOhio Medical Instrument Co., Inc.

Decision Date1999-11-02

Product CodeHAW

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

THE MAYFIELD / ACCISS SYSTEM WITH WINDOWS NT FOR CRANIAL SURGERY, THE MAYFIELD / OPTICAL ACCISS SYSTEM WITH WINDOWS NT F is the device name listed in this FDA 510(k) record. The listed applicant is Ohio Medical Instrument Co., Inc.. It received FDA 510(k) clearance on 1999-11-02 under 510(k) number K992843. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE MAYFIELD / ACCISS SYSTEM WITH WINDOWS NT FOR CRANIAL SURGERY, THE MAYFIELD / OPTICAL ACCISS SYSTEM WITH WINDOWS NT F?

THE MAYFIELD / ACCISS SYSTEM WITH WINDOWS NT FOR CRANIAL SURGERY, THE MAYFIELD / OPTICAL ACCISS SYSTEM WITH WINDOWS NT F is a medical device that received FDA 510(k) clearance on 1999-11-02. The listed applicant is Ohio Medical Instrument Co., Inc.. The 510(k) number is K992843.

When did THE MAYFIELD / ACCISS SYSTEM WITH WINDOWS NT FOR CRANIAL SURGERY, THE MAYFIELD / OPTICAL ACCISS SYSTEM WITH WINDOWS NT F receive FDA 510(k) clearance?

THE MAYFIELD / ACCISS SYSTEM WITH WINDOWS NT FOR CRANIAL SURGERY, THE MAYFIELD / OPTICAL ACCISS SYSTEM WITH WINDOWS NT F received FDA 510(k) clearance on 1999-11-02, under 510(k) number K992843.

Who is the listed applicant for THE MAYFIELD / ACCISS SYSTEM WITH WINDOWS NT FOR CRANIAL SURGERY, THE MAYFIELD / OPTICAL ACCISS SYSTEM WITH WINDOWS NT F?

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

What is the FDA product code for THE MAYFIELD / ACCISS SYSTEM WITH WINDOWS NT FOR CRANIAL SURGERY, THE MAYFIELD / OPTICAL ACCISS SYSTEM WITH WINDOWS NT F?

The FDA product code for THE MAYFIELD / ACCISS SYSTEM WITH WINDOWS NT FOR CRANIAL SURGERY, THE MAYFIELD / OPTICAL ACCISS SYSTEM WITH WINDOWS NT F is HAW.

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Other records listing Ohio Medical Instrument Co., 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.