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FDA 510(k)

TOMEY PROTON TONOMETER

K-Number: K924760 · 1993-04-05

ApplicantTomey Corporation USA
Decision Date1993-04-05
Product CodeHKY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

TOMEY PROTON TONOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Tomey Corporation USA. It received FDA 510(k) clearance on 1993-04-05 under 510(k) number K924760. 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 TOMEY PROTON TONOMETER?

TOMEY PROTON TONOMETER is a medical device that received FDA 510(k) clearance on 1993-04-05. The listed applicant is Tomey Corporation USA. The 510(k) number is K924760.

When did TOMEY PROTON TONOMETER receive FDA 510(k) clearance?

TOMEY PROTON TONOMETER received FDA 510(k) clearance on 1993-04-05, under 510(k) number K924760.

Who is the listed applicant for TOMEY PROTON TONOMETER?

The FDA 510(k) record lists Tomey Corporation USA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TOMEY PROTON TONOMETER?

The FDA product code for TOMEY PROTON TONOMETER is HKY.

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Other records listing Tomey Corporation USA 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.

K971953CONFOSCANK971685IMAGESCAPE DIGITAL RETINAL IMAGE SYSTEMK961805TOMEY DTL ELECTRODEK932571TOMEY PE-400 PORTABLE ERG & VEP WITH OPTIONAL PS-4K945959VIDEO VISION ANALYZER (VIVA), VRB 100K944910TOMEY EM-1000 SPECULAR MICROSCOPE

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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

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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