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FDA 510(k)

SIMULATOR

K-Number: K854265 · 1986-03-18

ApplicantCygnus of South Florida, Inc.
Decision Date1986-03-18
Product CodeJQP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Cygnus of South Florida, Inc.. It received FDA 510(k) clearance on 1986-03-18 under 510(k) number K854265. The device is classified under product code JQP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIMULATOR?

SIMULATOR is a medical device that received FDA 510(k) clearance on 1986-03-18. The listed applicant is Cygnus of South Florida, Inc.. The 510(k) number is K854265.

When did SIMULATOR receive FDA 510(k) clearance?

SIMULATOR received FDA 510(k) clearance on 1986-03-18, under 510(k) number K854265.

Who is the listed applicant for SIMULATOR?

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

What is the FDA product code for SIMULATOR?

The FDA product code for SIMULATOR is JQP.

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 Cygnus of South Florida, 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.

K860854CRITICALC

Related Devices (Code: JQP)

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.

K113007BIONIME DIABETES MANAGEMENT SYSTEM VI.0Bionime CorporationK983468FASTTAKE ADAPTER, MODEL # P/N 020-072-01Selfcare, Inc.K964460THE ROBOLITEShai Syg Motion and Innovations, Ltd.K953652PRENVAL IBase Ten Systems, Inc.K934111MR7000 WITH TIME MANAGER SOFTWARE (TMS)Dynatech Laboratories, Inc.K923316EXPRESSO CARTRIDGEBio-Rad Laboratories, Inc.

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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