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FDA 510(k)

AUTOMATED OPHTHALMICS SOFTIPS

K-Number: K992998 · 2000-01-10

ApplicantAutomated Ophthalmics, Inc.
Decision Date2000-01-10
Product CodeHKY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

AUTOMATED OPHTHALMICS SOFTIPS is the device name listed in this FDA 510(k) record. The listed applicant is Automated Ophthalmics, Inc.. It received FDA 510(k) clearance on 2000-01-10 under 510(k) number K992998. The device is classified under product code HKY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOMATED OPHTHALMICS SOFTIPS?

AUTOMATED OPHTHALMICS SOFTIPS is a medical device that received FDA 510(k) clearance on 2000-01-10. The listed applicant is Automated Ophthalmics, Inc.. The 510(k) number is K992998.

When did AUTOMATED OPHTHALMICS SOFTIPS receive FDA 510(k) clearance?

AUTOMATED OPHTHALMICS SOFTIPS received FDA 510(k) clearance on 2000-01-10, under 510(k) number K992998.

Who is the listed applicant for AUTOMATED OPHTHALMICS SOFTIPS?

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

What is the FDA product code for AUTOMATED OPHTHALMICS SOFTIPS?

The FDA product code for AUTOMATED OPHTHALMICS SOFTIPS is HKY.

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Related Devices (Code: HKY)

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.

K241447iCare ST500 (TA04)Icare Finland OYK233516Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)Reichert, Inc.K234037CATS-L Tonometer™ PrismCats Tonometer, LLCK232143Applanation Tonometer HT-5000Huvitz Co., Ltd.K220852iCare IC200Icare Finland OYK211355iCare HOME2Icare Finland OY

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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