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FDA 510(k)

VISION CARE/PHAKOSYSTEMS ECHOPACH

K-Number: K880081 · 1988-03-15

ApplicantPhakosystems, Inc.
Decision Date1988-03-15
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VISION CARE/PHAKOSYSTEMS ECHOPACH is the device name listed in this FDA 510(k) record. The listed applicant is Phakosystems, Inc.. It received FDA 510(k) clearance on 1988-03-15 under 510(k) number K880081. 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 VISION CARE/PHAKOSYSTEMS ECHOPACH?

VISION CARE/PHAKOSYSTEMS ECHOPACH is a medical device that received FDA 510(k) clearance on 1988-03-15. The listed applicant is Phakosystems, Inc.. The 510(k) number is K880081.

When did VISION CARE/PHAKOSYSTEMS ECHOPACH receive FDA 510(k) clearance?

VISION CARE/PHAKOSYSTEMS ECHOPACH received FDA 510(k) clearance on 1988-03-15, under 510(k) number K880081.

Who is the listed applicant for VISION CARE/PHAKOSYSTEMS ECHOPACH?

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

What is the FDA product code for VISION CARE/PHAKOSYSTEMS ECHOPACH?

The FDA product code for VISION CARE/PHAKOSYSTEMS ECHOPACH is IYO.

Related Clinical Trials

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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Other records listing Phakosystems, Inc. as applicant

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.

K871938VISION CARE/PHAKOSYSTEMS ECHORULEK860236PHAKOSYSTEMS CT-100 CAUTERY MODULEK851674PHAKOSYSTEMS MODEL CES 4100K830871PHAKOSYSTEMS MODEL 1000/OMNI PACKS IRRIGATION/ASPIRATION

Related Devices (Code: IYO)

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.

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.

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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