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FDA 510(k)

ORTHO 8000

K-Number: K963186 · 1996-11-12

ApplicantInner Vision Mri , Ltd.
Decision Date1996-11-12
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ORTHO 8000 is the device name listed in this FDA 510(k) record. The listed applicant is Inner Vision Mri , Ltd.. It received FDA 510(k) clearance on 1996-11-12 under 510(k) number K963186. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHO 8000?

ORTHO 8000 is a medical device that received FDA 510(k) clearance on 1996-11-12. The listed applicant is Inner Vision Mri , Ltd.. The 510(k) number is K963186.

When did ORTHO 8000 receive FDA 510(k) clearance?

ORTHO 8000 received FDA 510(k) clearance on 1996-11-12, under 510(k) number K963186.

Who is the listed applicant for ORTHO 8000?

The FDA 510(k) record lists Inner Vision Mri , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORTHO 8000?

The FDA product code for ORTHO 8000 is LNH.

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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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