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FDA 510(k)

PLATO 3000

K-Number: K933088 · 1994-02-25

ApplicantRosys, Inc.
Decision Date1994-02-25
Product CodeJQW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PLATO 3000 is the device name listed in this FDA 510(k) record. The listed applicant is Rosys, Inc.. It received FDA 510(k) clearance on 1994-02-25 under 510(k) number K933088. The device is classified under product code JQW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLATO 3000?

PLATO 3000 is a medical device that received FDA 510(k) clearance on 1994-02-25. The listed applicant is Rosys, Inc.. The 510(k) number is K933088.

When did PLATO 3000 receive FDA 510(k) clearance?

PLATO 3000 received FDA 510(k) clearance on 1994-02-25, under 510(k) number K933088.

Who is the listed applicant for PLATO 3000?

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

What is the FDA product code for PLATO 3000?

The FDA product code for PLATO 3000 is JQW.

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 Rosys, 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.

K943454PLATO 3300/1300

Related Devices (Code: JQW)

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.

K023955BD VIPER INSTRUMENTBecton, Dickinson & COK973335QUATRO SP SAMPLE PROCESSING SYSTEMS (200-499, INCLUSIVE)Zenyx Scientific , Ltd.K9801802700 SAMPLE MANAGERWaters CorporationK970420MASTERCAP AM 5.0/MASTERCAP RM 5.0Pharmacia, Inc.K970616MINI SAMPLER PROCESSORCavro Scientific Instruments, Inc.K962687GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEMNichols Institute Diagnostics

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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