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FDA 510(k)

COMPUTON(R)

K-Number: K863200 · 1986-09-03

ApplicantOptical Radiation Corp.
Decision Date1986-09-03
Product CodeHKX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

COMPUTON(R) is the device name listed in this FDA 510(k) record. The listed applicant is Optical Radiation Corp.. It received FDA 510(k) clearance on 1986-09-03 under 510(k) number K863200. 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 COMPUTON(R)?

COMPUTON(R) is a medical device that received FDA 510(k) clearance on 1986-09-03. The listed applicant is Optical Radiation Corp.. The 510(k) number is K863200.

When did COMPUTON(R) receive FDA 510(k) clearance?

COMPUTON(R) received FDA 510(k) clearance on 1986-09-03, under 510(k) number K863200.

Who is the listed applicant for COMPUTON(R)?

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

What is the FDA product code for COMPUTON(R)?

The FDA product code for COMPUTON(R) 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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Other records listing Optical Radiation 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.

K9207950R 160, OR-1.60, AND ORCOLITE 1.60 HIGH INDEXK853668ORC ORACLE

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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