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FDA 510(k)

AO NON-CONTACT II TONOMETER

K-Number: K802419 · 1980-11-12

ApplicantAmerican Optical Corp.
Decision Date1980-11-12
Product CodeHKX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

AO NON-CONTACT II TONOMETER is the device name listed in this FDA 510(k) record. The listed applicant is American Optical Corp.. It received FDA 510(k) clearance on 1980-11-12 under 510(k) number K802419. 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 AO NON-CONTACT II TONOMETER?

AO NON-CONTACT II TONOMETER is a medical device that received FDA 510(k) clearance on 1980-11-12. The listed applicant is American Optical Corp.. The 510(k) number is K802419.

When did AO NON-CONTACT II TONOMETER receive FDA 510(k) clearance?

AO NON-CONTACT II TONOMETER received FDA 510(k) clearance on 1980-11-12, under 510(k) number K802419.

Who is the listed applicant for AO NON-CONTACT II TONOMETER?

The FDA 510(k) record lists American Optical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AO NON-CONTACT II TONOMETER?

The FDA product code for AO NON-CONTACT II TONOMETER is HKX.

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Other records listing American Optical Corp. 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.

K950881PHACO TIPK950880AOI UNIVERSAL ULTRASONIC HANDPIECEK931354P4000 PHACOEMULSIFIERK931358AORP4000 REUSABLE PAKK931357AOD4000 DISPOSABLE PAKK820790FLEXIBLE PROCTOSIGMOIDOSCOPE, #FPS-3

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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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