Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

OPTICOM M600

K-Number: K932258 · 1994-07-25

ApplicantClement Clarke, Inc.
Decision Date1994-07-25
Product CodeHPT
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OPTICOM M600 is the device name listed in this FDA 510(k) record. The listed applicant is Clement Clarke, Inc.. It received FDA 510(k) clearance on 1994-07-25 under 510(k) number K932258. The device is classified under product code HPT. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTICOM M600?

OPTICOM M600 is a medical device that received FDA 510(k) clearance on 1994-07-25. The listed applicant is Clement Clarke, Inc.. The 510(k) number is K932258.

When did OPTICOM M600 receive FDA 510(k) clearance?

OPTICOM M600 received FDA 510(k) clearance on 1994-07-25, under 510(k) number K932258.

Who is the listed applicant for OPTICOM M600?

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

What is the FDA product code for OPTICOM M600?

The FDA product code for OPTICOM M600 is HPT.

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 Clement Clarke, 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.

K961512PERKINS HAND-HELD APPLANATION TONOMETERK952713MINI WRIGHT LR AFSK953965904 SLIT LAMPK914126VMX MINI-LOG FLOWMETERK914896FRIEDMANN ANALYSER 3K912397PROFESSIONAL INDIRECT OPHTHALMOSCOPE

View all 10 devices →

Related Devices (Code: HPT)

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.

K092187MAIA, MODEL 1Centervue S.P.A.K093213GUIDED PROGRESSION ANALYSIS ON THE HUMPHREY FIELD ANALYZER II AND II -I SERIESCarl Zeiss Meditec, Inc.K091579FORESEE HOMENotal Vision , Ltd.K063310TRUEFIELD ANALYZERSeeing Machines LimitedK050350THE NOTAL VISION PREVIEW PREFERENTIAL HYPERACUITY PERIMETER (PREVIEW PHP)Notal Vision, Inc.K023623NOVAVISION, MODEL 2.0Novavision, Inc.

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.

↑