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FDA 510(k)

DIGITAL AVERAGING TONOMETER

K-Number: K945972 · 1995-08-17

ApplicantOpti-Med Electronics
Decision Date1995-08-17
Product CodeHKX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

DIGITAL AVERAGING TONOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Opti-Med Electronics. It received FDA 510(k) clearance on 1995-08-17 under 510(k) number K945972. 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 DIGITAL AVERAGING TONOMETER?

DIGITAL AVERAGING TONOMETER is a medical device that received FDA 510(k) clearance on 1995-08-17. The listed applicant is Opti-Med Electronics. The 510(k) number is K945972.

When did DIGITAL AVERAGING TONOMETER receive FDA 510(k) clearance?

DIGITAL AVERAGING TONOMETER received FDA 510(k) clearance on 1995-08-17, under 510(k) number K945972.

Who is the listed applicant for DIGITAL AVERAGING TONOMETER?

The FDA 510(k) record lists Opti-Med Electronics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIGITAL AVERAGING TONOMETER?

The FDA product code for DIGITAL AVERAGING TONOMETER 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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