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FDA 510(k)

KOWA HAND-HELD APPLANATION TONOMETER HA-1

K-Number: K960924 · 1996-06-04

ApplicantKowa Optimed, Inc.
Decision Date1996-06-04
Product CodeHKY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

KOWA HAND-HELD APPLANATION TONOMETER HA-1 is the device name listed in this FDA 510(k) record. The listed applicant is Kowa Optimed, Inc.. It received FDA 510(k) clearance on 1996-06-04 under 510(k) number K960924. 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 KOWA HAND-HELD APPLANATION TONOMETER HA-1?

KOWA HAND-HELD APPLANATION TONOMETER HA-1 is a medical device that received FDA 510(k) clearance on 1996-06-04. The listed applicant is Kowa Optimed, Inc.. The 510(k) number is K960924.

When did KOWA HAND-HELD APPLANATION TONOMETER HA-1 receive FDA 510(k) clearance?

KOWA HAND-HELD APPLANATION TONOMETER HA-1 received FDA 510(k) clearance on 1996-06-04, under 510(k) number K960924.

Who is the listed applicant for KOWA HAND-HELD APPLANATION TONOMETER HA-1?

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

What is the FDA product code for KOWA HAND-HELD APPLANATION TONOMETER HA-1?

The FDA product code for KOWA HAND-HELD APPLANATION TONOMETER HA-1 is HKY.

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Other records listing Kowa Optimed, 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.

K013805KOWA AUTOMATED TONOMETER KT-500K961090AUTOMATIC VISUAL FIELD PLOTTER AP-125K955442KOWA SC-1200 PHOTO SLIT LAMP SYSTEMK954780KOWA PROFESSIONAL FUNDUS CAMERA MODELS FX-500, FX-500S, FX-500CK954781KOWA GENESIS HAND-HELD FUNDUS CAMERAK954782KOWA PORTABLE SLIT LAMP SL-14 & SL-14B

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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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