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FDA 510(k)

MAYFIELD ACCISS OPTICAL SYSTEM

K-Number: K982244 · 1998-09-23

ApplicantOhio Medical Instrument Co., Inc.
Decision Date1998-09-23
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MAYFIELD ACCISS OPTICAL 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 1998-09-23 under 510(k) number K982244. 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 OPTICAL SYSTEM?

MAYFIELD ACCISS OPTICAL SYSTEM is a medical device that received FDA 510(k) clearance on 1998-09-23. The listed applicant is Ohio Medical Instrument Co., Inc.. The 510(k) number is K982244.

When did MAYFIELD ACCISS OPTICAL SYSTEM receive FDA 510(k) clearance?

MAYFIELD ACCISS OPTICAL SYSTEM received FDA 510(k) clearance on 1998-09-23, under 510(k) number K982244.

Who is the listed applicant for MAYFIELD ACCISS OPTICAL 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 OPTICAL SYSTEM?

The FDA product code for MAYFIELD ACCISS OPTICAL SYSTEM is HAW.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K021604MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020K013428MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL ACCISS SYSTEMK992843THE MAYFIELD / ACCISS SYSTEM WITH WINDOWS NT FOR CRANIAL SURGERY, THE MAYFIELD / OPTICAL ACCISS SYSTEM WITH WINDOWS NT FK991267SPINE APPLICATIONS FOR THE MAYFIELD/ACCISS OPERATING ARM AND OPTICAL ACCISS SYSTEMS MODULE, MAYFIELD/ACCISS SPINE RING AK983282OMI OCCIPITAL CERVICAL LOOP, MODEL A1089K960807TEW 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.

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