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FDA 510(k)

2D VOG - VIDEO-OCULOGRAPHY

K-Number: K972243 · 1997-09-10

ApplicantSensomotoric Instruments, GmbH
Decision Date1997-09-10
Product CodeGWN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

2D VOG - VIDEO-OCULOGRAPHY is the device name listed in this FDA 510(k) record. The listed applicant is Sensomotoric Instruments, GmbH. It received FDA 510(k) clearance on 1997-09-10 under 510(k) number K972243. The device is classified under product code GWN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 2D VOG - VIDEO-OCULOGRAPHY?

2D VOG - VIDEO-OCULOGRAPHY is a medical device that received FDA 510(k) clearance on 1997-09-10. The listed applicant is Sensomotoric Instruments, GmbH. The 510(k) number is K972243.

When did 2D VOG - VIDEO-OCULOGRAPHY receive FDA 510(k) clearance?

2D VOG - VIDEO-OCULOGRAPHY received FDA 510(k) clearance on 1997-09-10, under 510(k) number K972243.

Who is the listed applicant for 2D VOG - VIDEO-OCULOGRAPHY?

The FDA 510(k) record lists Sensomotoric Instruments, GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 2D VOG - VIDEO-OCULOGRAPHY?

The FDA product code for 2D VOG - VIDEO-OCULOGRAPHY is GWN.

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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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