FDA 510(k)

MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL ACCISS SYSTEM

K-Number: K013428 · 2002-04-04

ApplicantOhio Medical Instrument Co., Inc.

Decision Date2002-04-04

Product CodeHAW

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL ACCISS SYSTEM 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 2002-04-04 under 510(k) number K013428. 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 MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL ACCISS SYSTEM?

MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL ACCISS SYSTEM is a medical device that received FDA 510(k) clearance on 2002-04-04. The listed applicant is Ohio Medical Instrument Co., Inc.. The 510(k) number is K013428.

When did MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL ACCISS SYSTEM receive FDA 510(k) clearance?

MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL ACCISS SYSTEM received FDA 510(k) clearance on 2002-04-04, under 510(k) number K013428.

Who is the listed applicant for MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL ACCISS SYSTEM?

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 MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL ACCISS SYSTEM?

The FDA product code for MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL ACCISS SYSTEM is HAW.

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Other records listing Ohio Medical Instrument Co., Inc. as applicant

K021604MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020 K992843THE MAYFIELD / ACCISS SYSTEM WITH WINDOWS NT FOR CRANIAL SURGERY, THE MAYFIELD / OPTICAL ACCISS SYSTEM WITH WINDOWS NT F K991267SPINE APPLICATIONS FOR THE MAYFIELD/ACCISS OPERATING ARM AND OPTICAL ACCISS SYSTEMS MODULE, MAYFIELD/ACCISS SPINE RING A K983282OMI OCCIPITAL CERVICAL LOOP, MODEL A1089 K982244MAYFIELD ACCISS OPTICAL SYSTEM K960807TEW CRANIAL/SPINAL RETRACTOR MODEL A1090

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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.