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FDA 510(k)

OPHTHAVISION IMAGING SYSTEM

K-Number: K980295 · 1998-05-19

ApplicantMrp Group, Inc.
Decision Date1998-05-19
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OPHTHAVISION IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Mrp Group, Inc.. It received FDA 510(k) clearance on 1998-05-19 under 510(k) number K980295. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPHTHAVISION IMAGING SYSTEM?

OPHTHAVISION IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 1998-05-19. The listed applicant is Mrp Group, Inc.. The 510(k) number is K980295.

When did OPHTHAVISION IMAGING SYSTEM receive FDA 510(k) clearance?

OPHTHAVISION IMAGING SYSTEM received FDA 510(k) clearance on 1998-05-19, under 510(k) number K980295.

Who is the listed applicant for OPHTHAVISION IMAGING SYSTEM?

The FDA 510(k) record lists Mrp Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPHTHAVISION IMAGING SYSTEM?

The FDA product code for OPHTHAVISION IMAGING SYSTEM is HKI.

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Related Devices (Code: HKI)

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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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