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FDA 510(k)

OPACITY LENSMETER 701

K-Number: K874355 · 1988-01-26

ApplicantIntraoptics, Inc.
Decision Date1988-01-26
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OPACITY LENSMETER 701 is the device name listed in this FDA 510(k) record. The listed applicant is Intraoptics, Inc.. It received FDA 510(k) clearance on 1988-01-26 under 510(k) number K874355. 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 OPACITY LENSMETER 701?

OPACITY LENSMETER 701 is a medical device that received FDA 510(k) clearance on 1988-01-26. The listed applicant is Intraoptics, Inc.. The 510(k) number is K874355.

When did OPACITY LENSMETER 701 receive FDA 510(k) clearance?

OPACITY LENSMETER 701 received FDA 510(k) clearance on 1988-01-26, under 510(k) number K874355.

Who is the listed applicant for OPACITY LENSMETER 701?

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

What is the FDA product code for OPACITY LENSMETER 701?

The FDA product code for OPACITY LENSMETER 701 is HKI.

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Related Devices (Code: HKI)

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

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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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