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FDA 510(k)

GLAUKON

K-Number: K820751 · 1982-04-09

ApplicantSonometrics Systems, Inc.
Decision Date1982-04-09
Product CodeHKX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

GLAUKON is the device name listed in this FDA 510(k) record. The listed applicant is Sonometrics Systems, Inc.. It received FDA 510(k) clearance on 1982-04-09 under 510(k) number K820751. 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 GLAUKON?

GLAUKON is a medical device that received FDA 510(k) clearance on 1982-04-09. The listed applicant is Sonometrics Systems, Inc.. The 510(k) number is K820751.

When did GLAUKON receive FDA 510(k) clearance?

GLAUKON received FDA 510(k) clearance on 1982-04-09, under 510(k) number K820751.

Who is the listed applicant for GLAUKON?

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

What is the FDA product code for GLAUKON?

The FDA product code for GLAUKON 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Sonometrics Systems, Inc. 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.

K812015GLAUKONK802341DIOSCANK781543ORBIOGRAPH

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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