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FDA 510(k)

RETINAL CUBE

K-Number: K973950 · 1997-12-12

ApplicantApplied Spectral Imaging , Ltd.
Decision Date1997-12-12
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

RETINAL CUBE is the device name listed in this FDA 510(k) record. The listed applicant is Applied Spectral Imaging , Ltd.. It received FDA 510(k) clearance on 1997-12-12 under 510(k) number K973950. 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 RETINAL CUBE?

RETINAL CUBE is a medical device that received FDA 510(k) clearance on 1997-12-12. The listed applicant is Applied Spectral Imaging , Ltd.. The 510(k) number is K973950.

When did RETINAL CUBE receive FDA 510(k) clearance?

RETINAL CUBE received FDA 510(k) clearance on 1997-12-12, under 510(k) number K973950.

Who is the listed applicant for RETINAL CUBE?

The FDA 510(k) record lists Applied Spectral Imaging , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RETINAL CUBE?

The FDA product code for RETINAL CUBE is HKI.

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Other records listing Applied Spectral Imaging , Ltd. as applicant

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Related Devices (Code: HKI)

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Official Source

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