FDA 510(k)

PHACO 20/20 SYSTEM I

K-Number: K915457 · 1992-02-24

ApplicantInnovative Medical Systems, Inc.

Decision Date1992-02-24

Product CodeHQC

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

PHACO 20/20 SYSTEM I is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Medical Systems, Inc.. It received FDA 510(k) clearance on 1992-02-24 under 510(k) number K915457. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHACO 20/20 SYSTEM I?

PHACO 20/20 SYSTEM I is a medical device that received FDA 510(k) clearance on 1992-02-24. The listed applicant is Innovative Medical Systems, Inc.. The 510(k) number is K915457.

When did PHACO 20/20 SYSTEM I receive FDA 510(k) clearance?

PHACO 20/20 SYSTEM I received FDA 510(k) clearance on 1992-02-24, under 510(k) number K915457.

Who is the listed applicant for PHACO 20/20 SYSTEM I?

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

What is the FDA product code for PHACO 20/20 SYSTEM I?

The FDA product code for PHACO 20/20 SYSTEM I is HQC.

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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.