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FDA 510(k)

IS-2000 DIGITAL OPHTHALMIC IMAGING SYSTEM

K-Number: K854330 · 1985-12-13

ApplicantPar Technology Park
Decision Date1985-12-13
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

IS-2000 DIGITAL OPHTHALMIC IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Par Technology Park. It received FDA 510(k) clearance on 1985-12-13 under 510(k) number K854330. 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 IS-2000 DIGITAL OPHTHALMIC IMAGING SYSTEM?

IS-2000 DIGITAL OPHTHALMIC IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 1985-12-13. The listed applicant is Par Technology Park. The 510(k) number is K854330.

When did IS-2000 DIGITAL OPHTHALMIC IMAGING SYSTEM receive FDA 510(k) clearance?

IS-2000 DIGITAL OPHTHALMIC IMAGING SYSTEM received FDA 510(k) clearance on 1985-12-13, under 510(k) number K854330.

Who is the listed applicant for IS-2000 DIGITAL OPHTHALMIC IMAGING SYSTEM?

The FDA 510(k) record lists Par Technology Park as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IS-2000 DIGITAL OPHTHALMIC IMAGING SYSTEM?

The FDA product code for IS-2000 DIGITAL OPHTHALMIC IMAGING SYSTEM 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.

K253176TearViewBeyond 700 Pty, Ltd.K251353Eyer 2Phelcom TechnologiesK252120Fundus On Phone Non Mydriatic (FOP NM-10)Remidio Innovative Solutions Private LimitedK250770Optina-4C (MHRC-C1N)Optina Diagnostics, Inc.K2436003nethra neo HD FA; 3nethra neo HDForus Health Pvt.LtdK250683Resolve Fundus CameraOptain Health, Inc.

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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