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FDA 510(k)

TONOPACH ULTRASONIC TONOMETER/PACHYMETER MODEL P-201 (THE TONOPACH)

K-Number: K042099 · 2004-12-10

ApplicantRetinapharma Technologies, Inc.
Decision Date2004-12-10
Product CodeHKX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

TONOPACH ULTRASONIC TONOMETER/PACHYMETER MODEL P-201 (THE TONOPACH) is the device name listed in this FDA 510(k) record. The listed applicant is Retinapharma Technologies, Inc.. It received FDA 510(k) clearance on 2004-12-10 under 510(k) number K042099. 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 TONOPACH ULTRASONIC TONOMETER/PACHYMETER MODEL P-201 (THE TONOPACH)?

TONOPACH ULTRASONIC TONOMETER/PACHYMETER MODEL P-201 (THE TONOPACH) is a medical device that received FDA 510(k) clearance on 2004-12-10. The listed applicant is Retinapharma Technologies, Inc.. The 510(k) number is K042099.

When did TONOPACH ULTRASONIC TONOMETER/PACHYMETER MODEL P-201 (THE TONOPACH) receive FDA 510(k) clearance?

TONOPACH ULTRASONIC TONOMETER/PACHYMETER MODEL P-201 (THE TONOPACH) received FDA 510(k) clearance on 2004-12-10, under 510(k) number K042099.

Who is the listed applicant for TONOPACH ULTRASONIC TONOMETER/PACHYMETER MODEL P-201 (THE TONOPACH)?

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

What is the FDA product code for TONOPACH ULTRASONIC TONOMETER/PACHYMETER MODEL P-201 (THE TONOPACH)?

The FDA product code for TONOPACH ULTRASONIC TONOMETER/PACHYMETER MODEL P-201 (THE TONOPACH) is HKX.

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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

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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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