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FDA 510(k)

PORTABLE NON-CONTACT TONOMETER, MODEL PT100

K-Number: K013259 · 2002-02-20

ApplicantLeica Microsystems, Inc. O.I.D.
Decision Date2002-02-20
Product CodeHKX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PORTABLE NON-CONTACT TONOMETER, MODEL PT100 is the device name listed in this FDA 510(k) record. The listed applicant is Leica Microsystems, Inc. O.I.D.. It received FDA 510(k) clearance on 2002-02-20 under 510(k) number K013259. The device is classified under product code HKX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PORTABLE NON-CONTACT TONOMETER, MODEL PT100?

PORTABLE NON-CONTACT TONOMETER, MODEL PT100 is a medical device that received FDA 510(k) clearance on 2002-02-20. The listed applicant is Leica Microsystems, Inc. O.I.D.. The 510(k) number is K013259.

When did PORTABLE NON-CONTACT TONOMETER, MODEL PT100 receive FDA 510(k) clearance?

PORTABLE NON-CONTACT TONOMETER, MODEL PT100 received FDA 510(k) clearance on 2002-02-20, under 510(k) number K013259.

Who is the listed applicant for PORTABLE NON-CONTACT TONOMETER, MODEL PT100?

The FDA 510(k) record lists Leica Microsystems, Inc. O.I.D. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PORTABLE NON-CONTACT TONOMETER, MODEL PT100?

The FDA product code for PORTABLE NON-CONTACT TONOMETER, MODEL PT100 is HKX.

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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Related Devices (Code: HKX)

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.

K253039AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIATopcon CorporationK223739VS Tabletop TonometerMedimaging Integrated Solution, Inc.K190382Intraocular Pressure Tonometer EASYTONCompany ElamedK181260MiiS Horus Scope DPT 100Medimaging Integrated Solution, Inc (Miis)K181143Keeler TonoCare TonometerKeeler Instruments, Inc.K180820Tono Vue Non-Contact TonometerCrystalvue Medical Corporation

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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