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FDA 510(k)

HUMPHREY OCT (OPTICAL COHERENCE TOMOGRAPHY) SCANNER

K-Number: K944523 · 1994-12-15

ApplicantHumphrey, Inc.
Decision Date1994-12-15
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HUMPHREY OCT (OPTICAL COHERENCE TOMOGRAPHY) SCANNER is the device name listed in this FDA 510(k) record. The listed applicant is Humphrey, Inc.. It received FDA 510(k) clearance on 1994-12-15 under 510(k) number K944523. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HUMPHREY OCT (OPTICAL COHERENCE TOMOGRAPHY) SCANNER?

HUMPHREY OCT (OPTICAL COHERENCE TOMOGRAPHY) SCANNER is a medical device that received FDA 510(k) clearance on 1994-12-15. The listed applicant is Humphrey, Inc.. The 510(k) number is K944523.

When did HUMPHREY OCT (OPTICAL COHERENCE TOMOGRAPHY) SCANNER receive FDA 510(k) clearance?

HUMPHREY OCT (OPTICAL COHERENCE TOMOGRAPHY) SCANNER received FDA 510(k) clearance on 1994-12-15, under 510(k) number K944523.

Who is the listed applicant for HUMPHREY OCT (OPTICAL COHERENCE TOMOGRAPHY) SCANNER?

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

What is the FDA product code for HUMPHREY OCT (OPTICAL COHERENCE TOMOGRAPHY) SCANNER?

The FDA product code for HUMPHREY OCT (OPTICAL COHERENCE TOMOGRAPHY) SCANNER is IYO.

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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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