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FDA 510(k)

OCULAR RESPONSE ANALYZER

K-Number: K081756 · 2008-08-07

ApplicantReichert, Inc.
Decision Date2008-08-07
Product CodeHKX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OCULAR RESPONSE ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Reichert, Inc.. It received FDA 510(k) clearance on 2008-08-07 under 510(k) number K081756. The device is classified under product code HKX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OCULAR RESPONSE ANALYZER?

OCULAR RESPONSE ANALYZER is a medical device that received FDA 510(k) clearance on 2008-08-07. The listed applicant is Reichert, Inc.. The 510(k) number is K081756.

When did OCULAR RESPONSE ANALYZER receive FDA 510(k) clearance?

OCULAR RESPONSE ANALYZER received FDA 510(k) clearance on 2008-08-07, under 510(k) number K081756.

Who is the listed applicant for OCULAR RESPONSE ANALYZER?

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

What is the FDA product code for OCULAR RESPONSE ANALYZER?

The FDA product code for OCULAR RESPONSE ANALYZER is HKX.

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Related Devices (Code: HKX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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